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Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284986
First Posted: February 1, 2006
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  Purpose
This study is designed to evaluate the safety and efficacy of Prochymal(TM) (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in subjects experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first line therapies and at least one second-line therapy.

Condition Intervention Phase
Graft Versus Host Disease Drug: Prochymal (TM) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Salvage of Treatment-Refractory Acute GVHD Patients

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):

Primary Outcome Measures:
  • Primary efficacy endpoint
  • - Response by Day 28

Secondary Outcome Measures:
  • Secondary efficacy endpoints
  • Improvement of GVHD by day 28 in one or more organs
  • involved with GVHD symptoms at day 1
  • Time to best overall GVHD grade
  • Best stage of each involved organ by day 28
  • Time to improvement or resolution of GVHD in one or
  • more organs
  • Safety Endpoints
  • Adverse events
  • Infusional toxicity
  • Overall relapse of underlying disease
  • Overall survival
  • Formation of ectopic tissue foci
  • Incidence of infection

Enrollment: 15
Study Start Date: November 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prochymal Drug: Prochymal (TM)

Detailed Description:
Allogeneic hematopoetic stem cell transplantation (HCT) is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Patients receiving HCT can develop a life threatening condition called graft versus host disease (GVHD). GVHD occurs when donor T cells from the donor bone marrow recognize host cells as "foreign" and initiate an inflammatory immunological response. The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus. This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some patients are refractory to current standard of care treatment. For treatment-refractory patients with grades III-IV GVHD mortality is approximately 80%. A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease.
  Eligibility

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Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 6 months to 70 years of age inclusive.
  • If female and of childbearing age, subjects must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception.
  • Subjects must have Grade III-IV acute GVHD that has failed to respond to standard first and at least one second-line therapy. Biopsy for confirmation of both skin and gastrointestinal GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
  • Subjects must have minimal renal function as defined by:Calculated CrCl of > 30 mL/min using the Cockroft Gault equation.
  • Subject must provide written informed consent and authorization for use and disclosure of PHI.

Exclusion Criteria:

  • Subject has uncontrolled alcohol or substance abuse within 6 months of treatment.
  • Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.).
  • Subject has a clinically significant, unstable arrhythmia.
  • Subject has a known allergy to bovine or porcine products.
  • Subject is unwilling to sign consent form for the long-term follow-up study, protocol No. 271
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284986


Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Mesoblast International Sàrl
Investigators
Principal Investigator: Joanne Kurtzberg, M.D. Duke University
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00284986     History of Changes
Other Study ID Numbers: Osiris 270
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
GVHD
Graft vs Host Disease
Graft versus Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases