Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy from Brain Hypoxia: a Phase II Clinical Trial

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 15, 2024

Primary Completion Date

October 15, 2026

Study Completion Date

January 31, 2027

Conditions
Autism Spectrum Disorder
Interventions
BIOLOGICAL

Autologous Bone Marrow Mononuclear Cell Transfusion

Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection.

OTHER

Rehabilitation

Rehabilitation methods involve various therapies tailored to the patient\'s mobility level. (1) Physical therapy focuses on exercises to control the head, neck, and trunk, manage muscle tone, and reduce spasticity. Patients gradually practice essential movements like rolling, sitting, crawling, standing, and walking, aligned with developmental milestones. (2) Occupational therapy aims to enhance fine motor skills and daily activities. Through hand function exercises, patients improve upper limb functionality, strengthen their ability to grasp and hold objects and refine coordination between both hands and hand-eye coordination. (3) Speech therapy improves communication, cognitive abilities, and chewing and swallowing functions. Specific exercises target lip and mouth movements, helping patients express and understand language better. Additionally, there are activities to strengthen jaw and facial muscles, which are essential for improving chewing and swallowing abilities.

Trial Locations (1)

100000

Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi

All Listed Sponsors
lead

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

NCT06629324 - Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy from Brain Hypoxia: a Phase II Clinical Trial | Biotech Hunter | Biotech Hunter