Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute GVHD

Expanded access is currently available for this treatment.
Verified October 2013 by Osiris Therapeutics
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00826046
First received: January 19, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

This protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. Patients must have failed to respond to steroid treatment for Grade C-D acute GVHD.


Condition Intervention
Graft-Versus-Host Disease
Drug: Prochymal®

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Resource links provided by NLM:


Further study details as provided by Osiris Therapeutics:

Intervention Details:
    Drug: Prochymal®
    Patients will be treated with Prochymal twice per week at a dose of 2 x 106 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
    Other Name: Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
Detailed Description:

This is a treatment protocol to provide patients who have failed steroid treatment for acute GVHD expanded access of Prochymal. It is anticipated that a maximum of 10 patients per month for a total of 120 patients per year will be treated according to this protocol.

Patients will be treated with Prochymal twice per week at a dose of 2 x 106 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Patients must be 18 years to 70 years of age, inclusive.
  • Biopsy confirmation of GVHD is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection.
  • Patients must have failed to respond to steroid treatment (methylprednisolone [≥1mg/kg/day] or equivalent) for Grades C-D acute GVHD.
  • Prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute GVHD.
  • Prochymal must be administered either before or at the same time any additional GVHD therapy is administered
  • Patients must have an adequate renal function as defined by Cockroft-Gault equation:Calculated creatinine clearance (CrCl) > 30mL/min
  • Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception.

Exclusion Criteria:

  • Patient has stage 3 or 4 liver GVHD, bilirubin >6 mg/dl.
  • Patient has stage 4 GI-GVHD.
  • Patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days.
  • Patient may not receive any other investigational agent (not approved by the FDA for any indication) concurrently for the duration of the protocol.
  • Patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2L of oxygen via face mask or an estimated FiO2of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
  • Patient has a known allergy to bovine or porcine products
  • Patient has a medical history of a solid tumor disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826046

Contacts
Contact: Farrell Newman 443-545-1812 fnewman@osiris.com

Locations
United States, Indiana
Indiana BMT
Beech Grove, Indiana, United States, 46107
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02284
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Osiris Therapeutics
Quintiles
  More Information

No publications provided

Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT00826046     History of Changes
Other Study ID Numbers: 276
Study First Received: January 19, 2009
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:
GVHD
Prochymal
Graft vs Host Disease

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

ClinicalTrials.gov processed this record on April 17, 2014