Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic stem cells and mesenchymal stromal cells in patients with spastic cerebral palsy on developmental function, a clinical trial phase 2

Cerebral palsy (CP) consisted of a group of non-progressive disorders of brain injuries ,and is one of the major problems of pediatric neurology and at the present time there is no standard medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of CP .This study designed for the evaluation of therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in improvement of developmental functions of spastic CP patients between 4-14 years old . Developmental conditions consisted of GMFM88, GMFCS, CP QOL-child, MACS and Stanford Binet and spasticity according to Ashworth scale and brain imaging findings documented at the start and during the study period. The patients referred to neurology clinic of Children’s Medical Center. Suitable cases selected from patients with remarkable cerebral damage of non-congenital origin in imaging. If parents after awareness of etiology and study design and even probable adverse effects have a consent, recruited. 108 cases will be recruited and randomly divided to 3 groups of 36 cases: hematopoietic stem cells derived from allogenic umbilical cord, Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators.

Keywords:

Cerebral palsy , Umbilical cord hematopoietic stem cells , Mesenchymal stem cells