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Summary

for people ages 2 months to 17 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Ongoing safety assessment follow up to Protocol MSB-GVHD 001 of remestemcel-L treatment in pediatric subjects 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.

Official Title

Safety Follow-up Through 180 Days of Treatment With Remestemcel-L in Study MSB-GVHD001 in Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Details

This is a safety follow-up study through 180 days of remestemcel-L treatment in subjects who participated in MSB-GVHD001. This study will also explore duration of response over time. Subjects who participated in MSB-GVHD001 and received at least one dose of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 for safety endpoints. Subjects who participated in Protocol MSB-GVHD001 and received the first 8 doses of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180.

Keywords

Grades B-D Acute Graft Versus Host Disease GVHD, Graft versus Host Disease Graft vs Host Disease

Eligibility

You can join if…

Open to people ages 2 months to 17 years

Patients are eligible for the study if all of the following criteria are met:

  • Subjects must have participated in gvhd001 and received at least one infusion of remestemcel L
  • Subject or subject'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 subjects 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 subject 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 CAN'T join if...

  • The investigator believes it to be in the best interest of the subject not to participate in the safety follow up study.

Locations

  • UCSF Benioff Children's Hospital in progress, not accepting new patients
    San Francisco, California, 94143, United States
  • Children's Hospital Los Angeles in progress, not accepting new patients
    Los Angeles, California, 90027, United States
  • CHOC Children's Hospital of Orange County accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mesoblast, Ltd.
ID
NCT02652130
Lead Scientist
Sandhya Kharbanda
Study Type
Observational
Last Updated
April 3, 2018