Safety and feasibility of third-party multipotent adult progenitor cells for immunomodulation therapy after liver transplantation--a phase I study (MISOT-I) View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-07-28

AUTHORS

Felix C Popp, Barbara Fillenberg, Elke Eggenhofer, Philipp Renner, Johannes Dillmann, Volker Benseler, Andreas A Schnitzbauer, James Hutchinson, Robert Deans, Deborah Ladenheim, Cheryl A Graveen, Florian Zeman, Michael Koller, Martin J Hoogduijn, Edward K Geissler, Hans J Schlitt, Marc H Dahlke

ABSTRACT

BackgroundLiver transplantation is the definitive treatment for many end-stage liver diseases. However, the life-long immunosuppression needed to prevent graft rejection causes clinically significant side effects. Cellular immunomodulatory therapies may allow the dose of immunosuppressive drugs to be reduced. In the current protocol, we propose to complement immunosuppressive pharmacotherapy with third-party multipotent adult progenitor cells (MAPCs), a culture-selected population of adult adherent stem cells derived from bone marrow that has been shown to display potent immunomodulatory and regenerative properties. In animal models, MAPCs reduce the need for pharmacological immunosuppression after experimental solid organ transplantation and regenerate damaged organs.MethodsPatients enrolled in this phase I, single-arm, single-center safety and feasibility study (n = 3-24) will receive 2 doses of third-party MAPCs after liver transplantation, on days 1 and 3, in addition to a calcineurin-inhibitor-free "bottom-up" immunosuppressive regimen with basiliximab, mycophenolic acid, and steroids. The study objective is to evaluate the safety and clinical feasibility of MAPC administration in this patient cohort. The primary endpoint of the study is safety, assessed by standardized dose-limiting toxicity events. One secondary endpoint is the time until first biopsy-proven acute rejection, in order to collect first evidence of efficacy. Dose escalation (150, 300, 450, and 600 million MAPCs) will be done according to a 3 + 3 classical escalation design (4 groups of 3-6 patients each).DiscussionIf MAPCs are safe for patients undergoing liver transplantation in this study, a phase II/III trial will be conducted to assess their clinical efficacy. More... »

PAGES

124

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1479-5876-9-124

DOI

http://dx.doi.org/10.1186/1479-5876-9-124

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1026411869

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21798013


Indexing Status Check whether this publication has been indexed by Scopus and Web Of Science using the SN Indexing Status Tool
Incoming Citations Browse incoming citations for this publication using opencitations.net

JSON-LD is the canonical representation for SciGraph data.

TIP: You can open this SciGraph record using an external JSON-LD service: JSON-LD Playground Google SDTT

[
  {
    "@context": "https://springernature.github.io/scigraph/jsonld/sgcontext.json", 
    "about": [
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/11", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Medical and Health Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "id": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/1103", 
        "inDefinedTermSet": "http://purl.org/au-research/vocabulary/anzsrc-for/2008/", 
        "name": "Clinical Sciences", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adult", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Adult Stem Cells", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Clinical Trials Data Monitoring Committees", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Feasibility Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Follow-Up Studies", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Humans", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Immunomodulation", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Immunosuppressive Agents", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Liver Transplantation", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Multipotent Stem Cells", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Risk Assessment", 
        "type": "DefinedTerm"
      }, 
      {
        "inDefinedTermSet": "https://www.nlm.nih.gov/mesh/", 
        "name": "Stem Cell Transplantation", 
        "type": "DefinedTerm"
      }
    ], 
    "author": [
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Popp", 
        "givenName": "Felix C", 
        "id": "sg:person.01001741457.76", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01001741457.76"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Fillenberg", 
        "givenName": "Barbara", 
        "id": "sg:person.01002600144.84", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01002600144.84"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Eggenhofer", 
        "givenName": "Elke", 
        "id": "sg:person.01010570514.05", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01010570514.05"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Renner", 
        "givenName": "Philipp", 
        "id": "sg:person.0632634064.57", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0632634064.57"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Dillmann", 
        "givenName": "Johannes", 
        "id": "sg:person.0666351544.40", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0666351544.40"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Benseler", 
        "givenName": "Volker", 
        "id": "sg:person.01215502761.03", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01215502761.03"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Schnitzbauer", 
        "givenName": "Andreas A", 
        "id": "sg:person.01255037551.33", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01255037551.33"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hutchinson", 
        "givenName": "James", 
        "id": "sg:person.01213367663.77", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01213367663.77"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Athersys Inc, Cleveland, Ohio, USA", 
          "id": "http://www.grid.ac/institutes/grid.423008.d", 
          "name": [
            "Athersys Inc, Cleveland, Ohio, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Deans", 
        "givenName": "Robert", 
        "id": "sg:person.01357032046.78", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01357032046.78"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Athersys Inc, Cleveland, Ohio, USA", 
          "id": "http://www.grid.ac/institutes/grid.423008.d", 
          "name": [
            "Athersys Inc, Cleveland, Ohio, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Ladenheim", 
        "givenName": "Deborah", 
        "id": "sg:person.0672212644.16", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0672212644.16"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Athersys Inc, Cleveland, Ohio, USA", 
          "id": "http://www.grid.ac/institutes/grid.423008.d", 
          "name": [
            "Athersys Inc, Cleveland, Ohio, USA"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Graveen", 
        "givenName": "Cheryl A", 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Zeman", 
        "givenName": "Florian", 
        "id": "sg:person.0606211770.22", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0606211770.22"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Koller", 
        "givenName": "Michael", 
        "id": "sg:person.0641632557.93", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0641632557.93"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands", 
          "id": "http://www.grid.ac/institutes/grid.5645.2", 
          "name": [
            "Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Hoogduijn", 
        "givenName": "Martin J", 
        "id": "sg:person.0644323430.22", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0644323430.22"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Geissler", 
        "givenName": "Edward K", 
        "id": "sg:person.0646270630.63", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646270630.63"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Schlitt", 
        "givenName": "Hans J", 
        "id": "sg:person.010361144542.53", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010361144542.53"
        ], 
        "type": "Person"
      }, 
      {
        "affiliation": {
          "alternateName": "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany", 
          "id": "http://www.grid.ac/institutes/grid.411941.8", 
          "name": [
            "Department of Surgery, University Medical Center Regensburg, Regensburg, Germany"
          ], 
          "type": "Organization"
        }, 
        "familyName": "Dahlke", 
        "givenName": "Marc H", 
        "id": "sg:person.01130660214.59", 
        "sameAs": [
          "https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01130660214.59"
        ], 
        "type": "Person"
      }
    ], 
    "citation": [
      {
        "id": "sg:pub.10.1007/s00423-007-0188-z", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1029382929", 
          "https://doi.org/10.1007/s00423-007-0188-z"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/nature00870", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040325841", 
          "https://doi.org/10.1038/nature00870"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1007/bf00314953", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1018125193", 
          "https://doi.org/10.1007/bf00314953"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1038/nri1435", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1040502284", 
          "https://doi.org/10.1038/nri1435"
        ], 
        "type": "CreativeWork"
      }, 
      {
        "id": "sg:pub.10.1186/1471-2369-11-24", 
        "sameAs": [
          "https://app.dimensions.ai/details/publication/pub.1000443477", 
          "https://doi.org/10.1186/1471-2369-11-24"
        ], 
        "type": "CreativeWork"
      }
    ], 
    "datePublished": "2011-07-28", 
    "datePublishedReg": "2011-07-28", 
    "description": "BackgroundLiver transplantation is the definitive treatment for many end-stage liver diseases. However, the life-long immunosuppression needed to prevent graft rejection causes clinically significant side effects. Cellular immunomodulatory therapies may allow the dose of immunosuppressive drugs to be reduced. In the current protocol, we propose to complement immunosuppressive pharmacotherapy with third-party multipotent adult progenitor cells (MAPCs), a culture-selected population of adult adherent stem cells derived from bone marrow that has been shown to display potent immunomodulatory and regenerative properties. In animal models, MAPCs reduce the need for pharmacological immunosuppression after experimental solid organ transplantation and regenerate damaged organs.MethodsPatients enrolled in this phase I, single-arm, single-center safety and feasibility study (n = 3-24) will receive 2 doses of third-party MAPCs after liver transplantation, on days 1 and 3, in addition to a calcineurin-inhibitor-free \"bottom-up\" immunosuppressive regimen with basiliximab, mycophenolic acid, and steroids. The study objective is to evaluate the safety and clinical feasibility of MAPC administration in this patient cohort. The primary endpoint of the study is safety, assessed by standardized dose-limiting toxicity events. One secondary endpoint is the time until first biopsy-proven acute rejection, in order to collect first evidence of efficacy. Dose escalation (150, 300, 450, and 600 million MAPCs) will be done according to a 3 + 3 classical escalation design (4 groups of 3-6 patients each).DiscussionIf MAPCs are safe for patients undergoing liver transplantation in this study, a phase II/III trial will be conducted to assess their clinical efficacy.", 
    "genre": "article", 
    "id": "sg:pub.10.1186/1479-5876-9-124", 
    "inLanguage": "en", 
    "isAccessibleForFree": true, 
    "isPartOf": [
      {
        "id": "sg:journal.1032886", 
        "issn": [
          "1479-5876"
        ], 
        "name": "Journal of Translational Medicine", 
        "publisher": "Springer Nature", 
        "type": "Periodical"
      }, 
      {
        "issueNumber": "1", 
        "type": "PublicationIssue"
      }, 
      {
        "type": "PublicationVolume", 
        "volumeNumber": "9"
      }
    ], 
    "keywords": [
      "multipotent adult progenitor cells", 
      "liver transplantation", 
      "adult progenitor cells", 
      "first biopsy-proven acute rejection", 
      "phase II/III trials", 
      "biopsy-proven acute rejection", 
      "end-stage liver disease", 
      "dose-limiting toxicity events", 
      "phase I", 
      "single-center safety", 
      "progenitor cells", 
      "solid organ transplantation", 
      "life-long immunosuppression", 
      "significant side effects", 
      "BackgroundLiver transplantation", 
      "immunosuppressive pharmacotherapy", 
      "immunosuppressive regimen", 
      "acute rejection", 
      "immunomodulatory therapy", 
      "primary endpoint", 
      "secondary endpoints", 
      "pharmacological immunosuppression", 
      "III trials", 
      "definitive treatment", 
      "dose escalation", 
      "immunomodulation therapy", 
      "liver disease", 
      "escalation design", 
      "immunosuppressive drugs", 
      "clinical efficacy", 
      "patient cohort", 
      "potent immunomodulatory", 
      "organ transplantation", 
      "side effects", 
      "animal models", 
      "bone marrow", 
      "day 1", 
      "transplantation", 
      "toxicity events", 
      "clinical feasibility", 
      "mycophenolic acid", 
      "immunosuppression", 
      "regenerative properties", 
      "study objective", 
      "therapy", 
      "stem cells", 
      "endpoint", 
      "efficacy", 
      "safety", 
      "current protocols", 
      "first evidence", 
      "adherent stem cells", 
      "cells", 
      "rejection causes", 
      "basiliximab", 
      "MethodsPatients", 
      "regimen", 
      "pharmacotherapy", 
      "patients", 
      "cohort", 
      "feasibility study", 
      "steroids", 
      "marrow", 
      "immunomodulatory", 
      "disease", 
      "dose", 
      "doses", 
      "administration", 
      "trials", 
      "drugs", 
      "study", 
      "treatment", 
      "organs", 
      "cause", 
      "escalation", 
      "population", 
      "rejection", 
      "evidence", 
      "feasibility", 
      "protocol", 
      "events", 
      "effect", 
      "acid", 
      "objective", 
      "need", 
      "addition", 
      "time", 
      "model", 
      "design", 
      "order", 
      "properties", 
      "bottom"
    ], 
    "name": "Safety and feasibility of third-party multipotent adult progenitor cells for immunomodulation therapy after liver transplantation--a phase I study (MISOT-I)", 
    "pagination": "124", 
    "productId": [
      {
        "name": "dimensions_id", 
        "type": "PropertyValue", 
        "value": [
          "pub.1026411869"
        ]
      }, 
      {
        "name": "doi", 
        "type": "PropertyValue", 
        "value": [
          "10.1186/1479-5876-9-124"
        ]
      }, 
      {
        "name": "pubmed_id", 
        "type": "PropertyValue", 
        "value": [
          "21798013"
        ]
      }
    ], 
    "sameAs": [
      "https://doi.org/10.1186/1479-5876-9-124", 
      "https://app.dimensions.ai/details/publication/pub.1026411869"
    ], 
    "sdDataset": "articles", 
    "sdDatePublished": "2022-05-20T07:26", 
    "sdLicense": "https://scigraph.springernature.com/explorer/license/", 
    "sdPublisher": {
      "name": "Springer Nature - SN SciGraph project", 
      "type": "Organization"
    }, 
    "sdSource": "s3://com-springernature-scigraph/baseset/20220519/entities/gbq_results/article/article_535.jsonl", 
    "type": "ScholarlyArticle", 
    "url": "https://doi.org/10.1186/1479-5876-9-124"
  }
]
 

Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1186/1479-5876-9-124'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1186/1479-5876-9-124'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1186/1479-5876-9-124'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1186/1479-5876-9-124'


 

This table displays all metadata directly associated to this object as RDF triples.

340 TRIPLES      22 PREDICATES      135 URIs      122 LITERALS      19 BLANK NODES

Subject Predicate Object
1 sg:pub.10.1186/1479-5876-9-124 schema:about N1ca6243c4baf4754a6e7b27806b80443
2 N226073a726514844973fa7d04e8a03bf
3 N23427c52cc374b7fa4dd2be9c4479864
4 N723aa919ad874232a6ab6d5a12c25f98
5 N75d139dcd4ab441783bede3851d3d575
6 Nae165b001a6e4a33b87d09f63d5653c2
7 Nb2d570a71eb24035926a54df835c7e8d
8 Nbddfef2316b742e58967c93811e94fc5
9 Nc1a7040d57f04488bd1a4cee25fca57d
10 Nd3e3c2d381854f91822d467f96faecaf
11 Nd5d6c8c052934b3088d4477aa1e10ec6
12 Ndc76dd9fcf174e6fbcc989bdad4816ea
13 anzsrc-for:11
14 anzsrc-for:1103
15 schema:author N9dbbff3ccfb34fcbb523337f60454344
16 schema:citation sg:pub.10.1007/bf00314953
17 sg:pub.10.1007/s00423-007-0188-z
18 sg:pub.10.1038/nature00870
19 sg:pub.10.1038/nri1435
20 sg:pub.10.1186/1471-2369-11-24
21 schema:datePublished 2011-07-28
22 schema:datePublishedReg 2011-07-28
23 schema:description BackgroundLiver transplantation is the definitive treatment for many end-stage liver diseases. However, the life-long immunosuppression needed to prevent graft rejection causes clinically significant side effects. Cellular immunomodulatory therapies may allow the dose of immunosuppressive drugs to be reduced. In the current protocol, we propose to complement immunosuppressive pharmacotherapy with third-party multipotent adult progenitor cells (MAPCs), a culture-selected population of adult adherent stem cells derived from bone marrow that has been shown to display potent immunomodulatory and regenerative properties. In animal models, MAPCs reduce the need for pharmacological immunosuppression after experimental solid organ transplantation and regenerate damaged organs.MethodsPatients enrolled in this phase I, single-arm, single-center safety and feasibility study (n = 3-24) will receive 2 doses of third-party MAPCs after liver transplantation, on days 1 and 3, in addition to a calcineurin-inhibitor-free "bottom-up" immunosuppressive regimen with basiliximab, mycophenolic acid, and steroids. The study objective is to evaluate the safety and clinical feasibility of MAPC administration in this patient cohort. The primary endpoint of the study is safety, assessed by standardized dose-limiting toxicity events. One secondary endpoint is the time until first biopsy-proven acute rejection, in order to collect first evidence of efficacy. Dose escalation (150, 300, 450, and 600 million MAPCs) will be done according to a 3 + 3 classical escalation design (4 groups of 3-6 patients each).DiscussionIf MAPCs are safe for patients undergoing liver transplantation in this study, a phase II/III trial will be conducted to assess their clinical efficacy.
24 schema:genre article
25 schema:inLanguage en
26 schema:isAccessibleForFree true
27 schema:isPartOf N1de8bd0719c047e890cc09484c8a5b08
28 Ne80933ad103d4fb9b8920aaa3dc438f1
29 sg:journal.1032886
30 schema:keywords BackgroundLiver transplantation
31 III trials
32 MethodsPatients
33 acid
34 acute rejection
35 addition
36 adherent stem cells
37 administration
38 adult progenitor cells
39 animal models
40 basiliximab
41 biopsy-proven acute rejection
42 bone marrow
43 bottom
44 cause
45 cells
46 clinical efficacy
47 clinical feasibility
48 cohort
49 current protocols
50 day 1
51 definitive treatment
52 design
53 disease
54 dose
55 dose escalation
56 dose-limiting toxicity events
57 doses
58 drugs
59 effect
60 efficacy
61 end-stage liver disease
62 endpoint
63 escalation
64 escalation design
65 events
66 evidence
67 feasibility
68 feasibility study
69 first biopsy-proven acute rejection
70 first evidence
71 immunomodulation therapy
72 immunomodulatory
73 immunomodulatory therapy
74 immunosuppression
75 immunosuppressive drugs
76 immunosuppressive pharmacotherapy
77 immunosuppressive regimen
78 life-long immunosuppression
79 liver disease
80 liver transplantation
81 marrow
82 model
83 multipotent adult progenitor cells
84 mycophenolic acid
85 need
86 objective
87 order
88 organ transplantation
89 organs
90 patient cohort
91 patients
92 pharmacological immunosuppression
93 pharmacotherapy
94 phase I
95 phase II/III trials
96 population
97 potent immunomodulatory
98 primary endpoint
99 progenitor cells
100 properties
101 protocol
102 regenerative properties
103 regimen
104 rejection
105 rejection causes
106 safety
107 secondary endpoints
108 side effects
109 significant side effects
110 single-center safety
111 solid organ transplantation
112 stem cells
113 steroids
114 study
115 study objective
116 therapy
117 time
118 toxicity events
119 transplantation
120 treatment
121 trials
122 schema:name Safety and feasibility of third-party multipotent adult progenitor cells for immunomodulation therapy after liver transplantation--a phase I study (MISOT-I)
123 schema:pagination 124
124 schema:productId N33627592fe8c49bb9e2e0711afcba59f
125 N3ff6c983b4b7498bbccd30402d9a5ec1
126 N637bb5a4014f4e18b5271d8b43e0e8fa
127 schema:sameAs https://app.dimensions.ai/details/publication/pub.1026411869
128 https://doi.org/10.1186/1479-5876-9-124
129 schema:sdDatePublished 2022-05-20T07:26
130 schema:sdLicense https://scigraph.springernature.com/explorer/license/
131 schema:sdPublisher N7a905b91cfce4e15a76ead32ffc24339
132 schema:url https://doi.org/10.1186/1479-5876-9-124
133 sgo:license sg:explorer/license/
134 sgo:sdDataset articles
135 rdf:type schema:ScholarlyArticle
136 N0005395f399f4e789b1a8ddeb3198092 rdf:first sg:person.010361144542.53
137 rdf:rest Nf51d0ca157224ee9a3a56b1bfa2f4e69
138 N0131af17c2754511a6e3b3070876683c rdf:first sg:person.01213367663.77
139 rdf:rest Na2f6fd212aca407fa653197bfa0165d1
140 N09cbf7868a1043c7bee623def0d1e026 rdf:first sg:person.0646270630.63
141 rdf:rest N0005395f399f4e789b1a8ddeb3198092
142 N16b32084a82049768b5b4bee3992ece3 rdf:first sg:person.0632634064.57
143 rdf:rest Na24ef0d4488347b8a3b8e37272b258c6
144 N1806f0eef60a4b79b048f5429aa16137 rdf:first sg:person.01215502761.03
145 rdf:rest Nb4930c3606734658b51193c0b51a2208
146 N1ca6243c4baf4754a6e7b27806b80443 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
147 schema:name Clinical Trials Data Monitoring Committees
148 rdf:type schema:DefinedTerm
149 N1de8bd0719c047e890cc09484c8a5b08 schema:issueNumber 1
150 rdf:type schema:PublicationIssue
151 N20cc933d821a40c89f21326ebc85dd71 rdf:first sg:person.0641632557.93
152 rdf:rest N5ef3e5fa23014f059620a5da6bf437b7
153 N226073a726514844973fa7d04e8a03bf schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
154 schema:name Stem Cell Transplantation
155 rdf:type schema:DefinedTerm
156 N23427c52cc374b7fa4dd2be9c4479864 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
157 schema:name Liver Transplantation
158 rdf:type schema:DefinedTerm
159 N33627592fe8c49bb9e2e0711afcba59f schema:name dimensions_id
160 schema:value pub.1026411869
161 rdf:type schema:PropertyValue
162 N375f55998b4c468a83695644b1c81ba1 schema:affiliation grid-institutes:grid.423008.d
163 schema:familyName Graveen
164 schema:givenName Cheryl A
165 rdf:type schema:Person
166 N3ff6c983b4b7498bbccd30402d9a5ec1 schema:name doi
167 schema:value 10.1186/1479-5876-9-124
168 rdf:type schema:PropertyValue
169 N5ef3e5fa23014f059620a5da6bf437b7 rdf:first sg:person.0644323430.22
170 rdf:rest N09cbf7868a1043c7bee623def0d1e026
171 N5f2e340ce139418fb28f4e60b41d71b2 rdf:first sg:person.01010570514.05
172 rdf:rest N16b32084a82049768b5b4bee3992ece3
173 N637bb5a4014f4e18b5271d8b43e0e8fa schema:name pubmed_id
174 schema:value 21798013
175 rdf:type schema:PropertyValue
176 N723aa919ad874232a6ab6d5a12c25f98 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
177 schema:name Immunomodulation
178 rdf:type schema:DefinedTerm
179 N75d139dcd4ab441783bede3851d3d575 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
180 schema:name Adult Stem Cells
181 rdf:type schema:DefinedTerm
182 N7a905b91cfce4e15a76ead32ffc24339 schema:name Springer Nature - SN SciGraph project
183 rdf:type schema:Organization
184 N7c77d68159634eed8d074d4974031ce7 rdf:first sg:person.0672212644.16
185 rdf:rest Na6b1adaf28674a8894265456524cbeb6
186 N83c76c396e33435cac3cefd591312bed rdf:first sg:person.0606211770.22
187 rdf:rest N20cc933d821a40c89f21326ebc85dd71
188 N9dbbff3ccfb34fcbb523337f60454344 rdf:first sg:person.01001741457.76
189 rdf:rest Nb2267b92d5b14198bfbf83a6f2368eea
190 Na24ef0d4488347b8a3b8e37272b258c6 rdf:first sg:person.0666351544.40
191 rdf:rest N1806f0eef60a4b79b048f5429aa16137
192 Na2f6fd212aca407fa653197bfa0165d1 rdf:first sg:person.01357032046.78
193 rdf:rest N7c77d68159634eed8d074d4974031ce7
194 Na6b1adaf28674a8894265456524cbeb6 rdf:first N375f55998b4c468a83695644b1c81ba1
195 rdf:rest N83c76c396e33435cac3cefd591312bed
196 Nae165b001a6e4a33b87d09f63d5653c2 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
197 schema:name Feasibility Studies
198 rdf:type schema:DefinedTerm
199 Nb2267b92d5b14198bfbf83a6f2368eea rdf:first sg:person.01002600144.84
200 rdf:rest N5f2e340ce139418fb28f4e60b41d71b2
201 Nb2d570a71eb24035926a54df835c7e8d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
202 schema:name Multipotent Stem Cells
203 rdf:type schema:DefinedTerm
204 Nb4930c3606734658b51193c0b51a2208 rdf:first sg:person.01255037551.33
205 rdf:rest N0131af17c2754511a6e3b3070876683c
206 Nbddfef2316b742e58967c93811e94fc5 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
207 schema:name Humans
208 rdf:type schema:DefinedTerm
209 Nc1a7040d57f04488bd1a4cee25fca57d schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
210 schema:name Risk Assessment
211 rdf:type schema:DefinedTerm
212 Nd3e3c2d381854f91822d467f96faecaf schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
213 schema:name Immunosuppressive Agents
214 rdf:type schema:DefinedTerm
215 Nd5d6c8c052934b3088d4477aa1e10ec6 schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
216 schema:name Adult
217 rdf:type schema:DefinedTerm
218 Ndc76dd9fcf174e6fbcc989bdad4816ea schema:inDefinedTermSet https://www.nlm.nih.gov/mesh/
219 schema:name Follow-Up Studies
220 rdf:type schema:DefinedTerm
221 Ne80933ad103d4fb9b8920aaa3dc438f1 schema:volumeNumber 9
222 rdf:type schema:PublicationVolume
223 Nf51d0ca157224ee9a3a56b1bfa2f4e69 rdf:first sg:person.01130660214.59
224 rdf:rest rdf:nil
225 anzsrc-for:11 schema:inDefinedTermSet anzsrc-for:
226 schema:name Medical and Health Sciences
227 rdf:type schema:DefinedTerm
228 anzsrc-for:1103 schema:inDefinedTermSet anzsrc-for:
229 schema:name Clinical Sciences
230 rdf:type schema:DefinedTerm
231 sg:journal.1032886 schema:issn 1479-5876
232 schema:name Journal of Translational Medicine
233 schema:publisher Springer Nature
234 rdf:type schema:Periodical
235 sg:person.01001741457.76 schema:affiliation grid-institutes:grid.411941.8
236 schema:familyName Popp
237 schema:givenName Felix C
238 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01001741457.76
239 rdf:type schema:Person
240 sg:person.01002600144.84 schema:affiliation grid-institutes:grid.411941.8
241 schema:familyName Fillenberg
242 schema:givenName Barbara
243 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01002600144.84
244 rdf:type schema:Person
245 sg:person.01010570514.05 schema:affiliation grid-institutes:grid.411941.8
246 schema:familyName Eggenhofer
247 schema:givenName Elke
248 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01010570514.05
249 rdf:type schema:Person
250 sg:person.010361144542.53 schema:affiliation grid-institutes:grid.411941.8
251 schema:familyName Schlitt
252 schema:givenName Hans J
253 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.010361144542.53
254 rdf:type schema:Person
255 sg:person.01130660214.59 schema:affiliation grid-institutes:grid.411941.8
256 schema:familyName Dahlke
257 schema:givenName Marc H
258 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01130660214.59
259 rdf:type schema:Person
260 sg:person.01213367663.77 schema:affiliation grid-institutes:grid.411941.8
261 schema:familyName Hutchinson
262 schema:givenName James
263 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01213367663.77
264 rdf:type schema:Person
265 sg:person.01215502761.03 schema:affiliation grid-institutes:grid.411941.8
266 schema:familyName Benseler
267 schema:givenName Volker
268 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01215502761.03
269 rdf:type schema:Person
270 sg:person.01255037551.33 schema:affiliation grid-institutes:grid.411941.8
271 schema:familyName Schnitzbauer
272 schema:givenName Andreas A
273 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01255037551.33
274 rdf:type schema:Person
275 sg:person.01357032046.78 schema:affiliation grid-institutes:grid.423008.d
276 schema:familyName Deans
277 schema:givenName Robert
278 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.01357032046.78
279 rdf:type schema:Person
280 sg:person.0606211770.22 schema:affiliation grid-institutes:grid.411941.8
281 schema:familyName Zeman
282 schema:givenName Florian
283 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0606211770.22
284 rdf:type schema:Person
285 sg:person.0632634064.57 schema:affiliation grid-institutes:grid.411941.8
286 schema:familyName Renner
287 schema:givenName Philipp
288 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0632634064.57
289 rdf:type schema:Person
290 sg:person.0641632557.93 schema:affiliation grid-institutes:grid.411941.8
291 schema:familyName Koller
292 schema:givenName Michael
293 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0641632557.93
294 rdf:type schema:Person
295 sg:person.0644323430.22 schema:affiliation grid-institutes:grid.5645.2
296 schema:familyName Hoogduijn
297 schema:givenName Martin J
298 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0644323430.22
299 rdf:type schema:Person
300 sg:person.0646270630.63 schema:affiliation grid-institutes:grid.411941.8
301 schema:familyName Geissler
302 schema:givenName Edward K
303 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0646270630.63
304 rdf:type schema:Person
305 sg:person.0666351544.40 schema:affiliation grid-institutes:grid.411941.8
306 schema:familyName Dillmann
307 schema:givenName Johannes
308 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0666351544.40
309 rdf:type schema:Person
310 sg:person.0672212644.16 schema:affiliation grid-institutes:grid.423008.d
311 schema:familyName Ladenheim
312 schema:givenName Deborah
313 schema:sameAs https://app.dimensions.ai/discover/publication?and_facet_researcher=ur.0672212644.16
314 rdf:type schema:Person
315 sg:pub.10.1007/bf00314953 schema:sameAs https://app.dimensions.ai/details/publication/pub.1018125193
316 https://doi.org/10.1007/bf00314953
317 rdf:type schema:CreativeWork
318 sg:pub.10.1007/s00423-007-0188-z schema:sameAs https://app.dimensions.ai/details/publication/pub.1029382929
319 https://doi.org/10.1007/s00423-007-0188-z
320 rdf:type schema:CreativeWork
321 sg:pub.10.1038/nature00870 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040325841
322 https://doi.org/10.1038/nature00870
323 rdf:type schema:CreativeWork
324 sg:pub.10.1038/nri1435 schema:sameAs https://app.dimensions.ai/details/publication/pub.1040502284
325 https://doi.org/10.1038/nri1435
326 rdf:type schema:CreativeWork
327 sg:pub.10.1186/1471-2369-11-24 schema:sameAs https://app.dimensions.ai/details/publication/pub.1000443477
328 https://doi.org/10.1186/1471-2369-11-24
329 rdf:type schema:CreativeWork
330 grid-institutes:grid.411941.8 schema:alternateName Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany
331 Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
332 schema:name Center for Clinical Studies, University Medical Center Regensburg, Regensburg, Germany
333 Department of Surgery, University Medical Center Regensburg, Regensburg, Germany
334 rdf:type schema:Organization
335 grid-institutes:grid.423008.d schema:alternateName Athersys Inc, Cleveland, Ohio, USA
336 schema:name Athersys Inc, Cleveland, Ohio, USA
337 rdf:type schema:Organization
338 grid-institutes:grid.5645.2 schema:alternateName Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
339 schema:name Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
340 rdf:type schema:Organization
 




Preview window. Press ESC to close (or click here)


...