Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy

Sung Kwang Medical Foundation

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Placebo Umbilical Cord Blood; Other: Placebo Erythropoietin; Biological: Umbilical Cord Blood Infusion; Other: Active Rehabilitation; Drug: Erythropoietin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01193660

RCTUBSC

PBC09-095 (Other Identifier)

Details and patient eligibility

About

This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.

Full description

Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery.

It is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well.

Although autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved.

Enrollment: 105 patients

Sex: All

Ages: 10 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known cerebral palsy
• Willing to comply with all study procedure

Exclusion criteria

• High risk of pneumonia or renal function deterioration after using of immunosuppressant
• Presence of known genetic disease
• Possibility of drug hypersensitivity which is related to this study remedy
• History of previous cell therapy
• Poor cooperation of guardian,including inactive attitude for rehabilitation
• Intractable seizure disorder
• Autism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups, including a placebo group

Umbilical Cord Blood & Erythropoietin & Rehabilitation

Experimental group

Description:

Allogenic umbilical cord blood infusion, erythropoietin injection \& active rehabilitation

Treatment:

Drug: Erythropoietin Injection

Biological: Umbilical Cord Blood Infusion

Other: Active Rehabilitation

Erythropoietin & Rehabilitation

Active Comparator group

Description:

Erythropoietin injection, active rehabilitation

Treatment:

Drug: Erythropoietin Injection

Other: Active Rehabilitation

Other: Placebo Umbilical Cord Blood

Only Rehabilitation

Placebo Comparator group

Description:

Active rehabilitation

Treatment:

Other: Active Rehabilitation

Other: Placebo Erythropoietin

Other: Placebo Umbilical Cord Blood