A Study of UCB and MSCs in Children With CP: ACCeNT-CP

Summary

The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy. In addition, this study will contribute much needed data to the clinical trials community on the natural history of the motor function in CP over short-term (less than 1 year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB and hCT-MSC infusion in children with cerebral palsy.

Timeline

Start

2018-04-10

Primary completion

2020-02-26

Completion

2021-05-31

Publications

• Liu J, Poehlein E, Chow SC. Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials. Ther Innov Regul Sci. 2023 Nov;57(6):1238-1247. doi: 10.1007/s43441-023-00556-8. Epub 2023 Aug 9.
• Sun JM, Case LE, McLaughlin C, Burgess A, Skergan N, Crane S, Jasien JM, Mikati MA, Troy J, Kurtzberg J. Motor function and safety after allogeneic cord blood and cord tissue-derived mesenchymal stromal cells in cerebral palsy: An open-label, randomized trial. Dev Med Child Neurol. 2022 Dec;64(12):1477-1486. doi: 10.1111/dmcn.15325. Epub 2022 Jul 10.

Drugs

Indications