- Study Details: IMPACT -
Cell Therapy in Children Diagnosed with Autism
The Duke Marcus Center IMPACT Clinical Trial is testing a new cell therapy. This phase II randomized ("flip of a coin"), blinded, placebo-controlled clinical trial is testing whether cell therapy can help improve social and communication skills in children diagnosed with autism.
Pro#: 00102894
Criteria: Children 4-11 years of age with a diagnosis of autism. Other requirements apply, which will be discussed during screening for eligibility.
Enrollment status: Enrollment is closed.
Date: May 15, 2020 - June 15, 2022
- Additional Study Team Members -
Co-investigators
- Scott Compton, PhD
- Nicole Heilbron, PhD
- Jill Howard, PhD
- Lynn Chatham, PhD
- Barbara Waters-Pick, BS, MT (ASCP)
- Guillermo Sapiro, PhD
- Jesse Troy, PhD, MPH
- Saritha Vermeer, PhD
- Elena Tenenbaum, PhD
- Jacqueline Flowers, PhD
- Lauren Franz, MBChB
Clinical Research Coordinators
- Lauren Driggers-Jones, PhD
- Alicia Burgess
- Related Journal Articles -
- Sun, Jessica M., and Joanne Kurtzberg. “Stem cell therapies in cerebral palsy and autism spectrum disorder.” Dev Med Child Neurol 63, no. 5 (May 2021): 503–10. https://doi.org/10.1111/dmcn.14789.
- Borre, Ethan D., Evan Myers, Marianne Hamilton -Lopez, Geraldine Dawson, Joanne Kurtzberg, Jesse Troy, and Gillian D. Sanders. “PROJECTING THE LONG-TERM CLINICAL AND ECONOMIC IMPACT OF AUTOLOGOUS CORD BLOOD INFUSION IN CHILDREN WITH AUTISM.” In Medical Decision Making, 41:E31–32, 2021.
- Sun, Jessica M., Geraldine Dawson, Lauren Franz, Jill Howard, Colleen McLaughlin, Bethany Kistler, Barbara Waters-Pick, Norin Meadows, Jesse Troy, and Joanne Kurtzberg. “Infusion of human umbilical cord tissue mesenchymal stromal cells in children with autism spectrum disorder.” Stem Cells Transl Med 9, no. 10 (October 2020): 1137–46. https://doi.org/10.1002/sctm.19-0434.
- Simhal, Anish K., Kimberly L. H. Carpenter, Saad Nadeem, Joanne Kurtzberg, Allen Song, Allen Tannenbaum, Guillermo Sapiro, and Geraldine Dawson. “Measuring robustness of brain networks in autism spectrum disorder with Ricci curvature.” Sci Rep 10, no. 1 (July 2, 2020): 10819. https://doi.org/10.1038/s41598-020-67474-9.
- Dawson, Geraldine, Jessica M. Sun, Jennifer Baker, Kimberly Carpenter, Scott Compton, Megan Deaver, Lauren Franz, et al. “A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder.” J Pediatr 222 (July 2020): 164-173.e5. https://doi.org/10.1016/j.jpeds.2020.03.011.