Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders

University of California, San Francisco (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

This study performs HLA matched stem cell transplantation from unrelated donors in adults who require stem cell transplantation but do not have a matched related donor available. The incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded. This study also monitors the activity and toxicity of total body irradiation and cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This protocol identifies a standard-of-care method for unrelated stem cell transplantation in adults. Performing this service in a consistent and documented fashion allows investigators to obtain informed consent from recipients. Data is tabulated locally for quality-control comparisons with nationally-reported standards. As a condition of maintaining transplant center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome data to the NMDP. As a result, UCSF is contributing to the resolution of remaining uncertainties regarding particular transplantation practices.

    Study Design

    Study Type:
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Standard of Care Trial: Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
    Study Start Date :
    Jan 1, 1999
    Actual Primary Completion Date :
    Jun 1, 2009
    Actual Study Completion Date :
    Jun 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria


      Ages Eligible for Study:
      16 Years to 54 Years
      Sexes Eligible for Study:
      Accepts Healthy Volunteers:
      Inclusion Criteria:
      • Age >15 and <55

      • Adequate renal function with serum creatinine <2.0 mg/dl

      • Pulmonary diffusing capacity>50% of predicted

      • Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography

      • Total bilirubin must be <2.5 mg/dl.

      • Alkaline phosphatase and AST must be less than three times the upper limit of normal

      • Negative serology for the human immunodeficiency virus

      • Available HLA-matched donor

      • Signed informed consent

      Exclusion Criteria:
      • No fully or single-antigen-mismatched sibling donor is available to donate stem cells

      • No active liver disease.

      Contacts and Locations


      Site City State Country Postal Code
      1 University of California San Francisco San Francisco California United States 94143

      Sponsors and Collaborators

      • University of California, San Francisco


      • Principal Investigator: Thomas G. Martin, M.D., University of California, San Francisco

      Study Documents (Full-Text)

      None provided.

      More Information


      None provided.
      Responsible Party:
      University of California, San Francisco
      ClinicalTrials.gov Identifier:
      Other Study ID Numbers:
      • UC-9907-CC99251
      First Posted:
      Aug 6, 2007
      Last Update Posted:
      Aug 2, 2013
      Last Verified:
      Aug 1, 2013

      Study Results

      No Results Posted as of Aug 2, 2013