Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD)

NCT00826046 | Unknown

• 1 other identifier: 276
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Graft-Versus-Host Disease

Keywords

GVHD; Prochymal; Graft vs Host Disease

Interventions

Prochymal® DRUG

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.

Also known as: Ex-vivo Cultured Adult Human Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Cockcroft-Gault equation:Calculated creatinine clearance (CrCl) \> 30 mL/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.

You may not qualify if:

• 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 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (FiO2) of 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.

Sponsors & Collaborators

• Mesoblast, Inc.: lead

Study Sites (3)

Indiana BMT

Beech Grove, Indiana, 46107, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02284, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

remestemcel-l

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Mahboob Rahman, MD

  Mesoblast, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

US (3)