NCT04098029

Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP

The Protocol of Estimation of the Safety and Efficiency of the Method of Transfusion of UCB Hemopoietic Cells to the Patients With Diagnosed Infantile Cerebral Palsy Depending on the Degrees of Compatibility of Donor and Recipient

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty" · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood-onset disability. Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in the brain. Based on many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy. This protocol was developed based on the results of the previously approved protocol of the center NCT03826498 (Allogeneic cord blood transfusion in patients with infantile cerebral palsy), which showed high efficiency in the rehabilitation of patients. The present protocol is intended for revealing the dependence of the clinical effect on the degree of tissue compatibility of umbilical cord blood samples and the recipient

Detailed description

Cerebral palsy (CP) is a group of neurodevelopmental conditions with abnormal movement and posture resulted from a non-progressive cerebral disturbance. It is the most common cause of motor disability in childhood. Most therapies are palliative rather than restorative. Umbilical cord blood (UCB) may be used as restorative approach for children with CP. Many experimental animal studies have revealed that UCB is beneficial to improve and repair neurological injuries, this effect achieved due to immune regulation and angiogenesis as well as the neuroprotective effect. Based on animal studies and some clinical trials, UCB is suggested as a potential therapy for children with CP. This study is prospective, non randomized (open label) with control group СLINICAL PURPOSES Estimation of the efficiency of the method of transfusion of umbilical blood hematopoietic cells to patients with diagnosed infantile cerebral palsy depending on the degrees of compatibility of donor and recipient. RESEARCH PURPOSES 1. To develop an algorithm of using the method of transfusion of hematopoietic cells of umbilical cord blood at complex therapy of patients with children's cerebral palsy. 2. Formulate criteria for selecting patients for this method. 3. To analyze the safety and efficacy of umbilical cord blood hematopoietic cells transfusion in patients with cerebral palsy using evaluation scales. 4. To compare the efficacy of treatment of patients depending on the degree of tissue compatibility of the donor and recipient and other laboratory indications. 5. To implement the method of transfusion of umbilical cord blood hematopoietic cells in the complex therapy of patients with cerebral palsy.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Low HLA group CBU infusion	CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 3 or fewer by A, B, DRB1 loci.
BIOLOGICAL	High HLA group CBU infusion	CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10\^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 4 or more by A, B, DRB1 loci.
OTHER	Standard therapy	The standard therapy can include drugs, special psychology training, etc.

Timeline

• Start date: 2019-09-01
• Primary completion: 2023-12-26
• Completion: 2024-05-26
• First posted: 2019-09-20
• Last updated: 2023-01-18

Locations

1 site across 1 country: Russia