Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

Status and phase: Enrolling; Phase 2

Conditions: Cerebral Palsy

Treatments: Other: Standard therapy; Biological: CP CB-MNC injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03826498

12102017

Details and patient eligibility

About

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 brain.

On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis: Cerebral Palsy.

Exclusion criteria

• the presence of the following diseases in history: heart failure in the stage of decompensation, stroke in history less than 1 year ago, blood diseases;
• decompensation of chronic and endocrinological diseases;
• acute respiratory viral and bacterial infections, period less than 1 month after the acute phase.
• HIV infection, hepatitis B and C.
• oncological diseases, chemotherapy in the anamnesis;
• tuberculosis.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

CP CB-MNC injection

Experimental group

Description:

CP CB-MNC injection from different donors and standard therapy.

Treatment:

Other: Standard therapy

Biological: CP CB-MNC injection

Standard therapy

Other group

Description:

Patients with standard therapy as control group

Treatment:

Other: Standard therapy