hCT-MSC in Children with Autism Spectrum Disorder (IMPACT)
This is a phase II randomized (flip of a coin), blinded, placebo-controlled clinical trial testing whether an IV infusion of hCT-MSCs helps decrease symptoms of Autism in young children. All participants will receive 2 IV infusions given six months apart. One infusion will be hCT-MSCs, and one will be an inactive placebo product. Participants and families will not know the order in which the products are given.
Participant reimbursement will be provided after the baseline visit and the one year remote visit.
- 4 to 11 years of age
- Diagnosis of Autism Spectrum Disorder
- Able to cooperate with testing
*Other requirements will apply.
Principal Investigators: Drs. Joanne Kurtzberg, Geraldine Dawson and Jessica Sun
Clinicaltrials.gov: NCT04089579, Duke Pro00102894