Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Completed · Phase 3

Conditions studied: Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease, Grade D Acute Graft Versus Host Disease

In brief

Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with systemic corticosteroid therapy.

Key facts

Study ID

NCT02652130

Run by

Mesoblast, Inc.

People needed

32

Starts

2015-10-28

Expected to finish

2018-06-15

Last updated by the study team

2022-03-16

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have participated in MSB-GVHD001 and have received at least one infusion of remestemcel-L.
• Participant or participant's authorized representative must be capable of providing written informed consent. Assent, if applicable, must also be collected when required by the Institutional Review Board (IRB)/Ethics Committee (EC).
• Female participants of childbearing potential (≥ 10 years of age) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
• The participant must be willing and able to comply with study procedures, remain at the clinic as required during the study period, and return to the clinic for the follow-up evaluation as specified in this protocol.

You may not qualify if…

• The investigator believes it to be in the best interest of the participant not to participate in the safety follow-up study.
• Participant has participated or is currently participating in any autologous or allogeneic stem cell or gene therapy study for the treatment of aGVHD. Participants participating in investigative protocols aimed at modification of the transplant graft (such as T cell depletion) or aimed at modification of the conditioning regimen will be allowed in the study.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• CHOC Children's Hospital of Orange County — Orange, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Children's Hospital Colorado Center for Cancer/Blood Disorders — Aurora, Colorado, United States
• Alfred I. duPont Hospital for Children of the Nemours Foundation — Wilmington, Delaware, United States
• Miami Children's Research Institute — Miami, Florida, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The Children's Hospital at Montefiore — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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