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

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.

Inclusion Criteria:

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.

Exclusion Criteria:

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