Clinical trial NCT03826498: Allogenic Cord Blood Transfusion in Patients With Cerebral Palsy
Official title: Efficiency Evaluation of Allogenic Umbilical Cord Blood Mononuclear Cells (UCB-MNC) Transfusion in Patients With Autism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
CP
Cord Blood
Stem cells
Lead sponsor: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 brain.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with non-serious and serious adverse events
timeFrame: 6 month
measure: Changes in Standardized Gross Motor Function 66 (GMFM-66) Score for all child.
timeFrame: 1, 3, 6 month
measure: Changes in Cognitive Neurodevelopmental Outcome for child before 3yrs
timeFrame: 1, 3, 6 month
measure: Changes in The Infant Toddler Quality of Life Questionnaire for child above 3yrs.
timeFrame: 1, 3, 6 month
measure: Changes in Ashworth scale score for all child.
timeFrame: 1, 3, 6 month
Secondary outcomes:
measure: Number of Participants with Chimerism (longevity) of infused cell
timeFrame: 6 month
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Medical Centre Dinasty
Study officials:
affiliation: Medical Centre Dinasty
name: STANISLAV VOLCHKOV, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: