Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia
Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial
About This Trial
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia. The key questions the study seeks to answer are: * What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation? * How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy? * How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation? Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups: * Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route. * Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline. * Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
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.
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.