Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP (NCT04098029) | Clinical Trial Compass
UnknownPhase 2
Estimation of the Safety and Efficiency Transfusion of HLA Matched CBU in Patients With CP
Russia150 participantsStarted 2019-09-01
Plain-language 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
Who can participate
Age range
1 Year – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patient selection criteria (indications for this type of treatment):
* Patient age from 1 to 12 years;
* Diagnosis: cerebral palsy, including postnatal damage after ischemic or hemorrhagic strokes, hypoxic or ischemic encephalopathy, periventricular leucomalacia;
* The presence of I - V lesion levels on the GMFCS - ER (CanChild) scale;
* The presence of a compatible allogeneic sample suitable for infusion;
* Parental consent (official guardians)
Patient exclusion criteria (contraindications for this type of treatment):
* Patient age up to 1 year, older than 12 years;
* The presence of the following diseases in history: heart failure in the stage of decompensation, anemia and other blood diseases;
* Decompensation of chronic and endocrinological diseases;
* Acute viral and bacterial infections during the acute clinical phase of the disease;
* HIV infection, hepatitis of B and C types;
* Oncological diseases, chemotherapy in the anamnesis;
* Tuberculosis;
* Confirmed genetic disorders;
* A severe form of intellectual disability as a concomitant disease (diagnosis can be ignored, according to the decision of the Medical Committee of the Center);
* Epileptic seizures with or without medication in the last 6 months before inclusion in the protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with non-serious and serious adverse events
Timeframe: 1 year
2
Gross Motor Function Classification System (GMFCS - ER) scale severity change
Timeframe: Baseline, 6 month after first infusion, 6 month after second infusion (3 times)
3
Changes in Standardized Gross Motor Function 66 (GMFM-66) Score for all child.
Timeframe: Baseline, 6 month after first infusion, 6 month after second infusion (3 times)
4
Changes in The Infant Toddler Quality of Life Questionnaire for child above 3yrs.
Timeframe: Baseline, 6 month after first infusion, 6 month after second infusion (3 times)
5
Changes in Ashworth scale score for all child.
Timeframe: Baseline, 6 month after first infusion, 6 month after second infusion (3 times)
Trial details
NCT IDNCT04098029
SponsorState-Financed Health Facility "Samara Regional Medical Center Dinasty"