Efficacy of Stem Cell Transplantation Compared to Rehabilitation Treatment of Patients With Cerebral Paralysis

NCT01929434 | Completed Phase 3 DMC

• 1 other identifier: 2013-05-13 CP III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP) is described as a group of permanent disorders affecting motor development and posture, resulting in activity limitation attributed to nonprogressive disturbances of the fetal or infant brain. The prevalence of cerebral palsy has increased among the children with low birth-weight, jaundice, respiratory distress and intrauterine infection and so on. The incidence of cerebral palsy is increasing gradually with increased neonatal survival rate. Although there are many kinds of functional therapy programs especially the rehabilitation treatment for cerebral palsy, their effects are limited. Increasing cerebral palsy patients become a heavy burden to the family and society. Stem cell based therapy, a new prospective therapy for central nervous system disorders, has the potential to repair the damaged brain tissue in patients with cerebral palsy. In this study, 300 patients with cerebral palsy will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 CP patients of them randomly. We will also follow up the other 100 patients who only receive rehabilitation treatment and another 100 patients who accept neither stem cell therapy nor rehabilitation treatment. On this basis, as the investigators we can compare the efficacy of cell therapy and rehabilitation treatments for cerebral palsy patients. Multiple sources of assessment were used to ascertain and classify all cases of cerebral palsy. Particularly the Gross Motor Function Measure (GMFM) as an important valid and reliable outcome measure, has made it possible to evaluate the severity of movement disability，change over time and the effects of clinical interventions. It also will be the primary outcome measure in follow-up analysis of this study.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; cell transplantation; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure Score

  Gross Motor Function Measure-88 and Gross Motor Function Measure-66

  Change from baseline at 12 monthes after enrollment or transplantation

Secondary Outcomes (1)

• Routine Blood Test and Biochemical Test

  Change from baseline at 12 monthes after enrollment or transplantation

Other Outcomes (1)

• Magnetic resonance imaging （MRI）

  Change from baseline at 12 monthes after enrollment or transplantation

Study Arms (3)

rehabilitation

ACTIVE COMPARATOR

Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.

Other: rehabilitation

control

NO INTERVENTION

Patients receive no professional treatment in hospital or rehabilitation centre.

stem cell injection

EXPERIMENTAL

Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.

Biological: stem cell injection

Interventions

rehabilitation OTHER

Patients only receive rehabilitation of physical therapy and occupational therapy.

Also known as: phsical exercise rehabilitation

rehabilitation

stem cell injection BIOLOGICAL

Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.

stem cell injection

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with diagnosis of cerebral palsy.
• Patients' curator must be able to give voluntary consent.

You may not qualify if:

• Intracranial infection.
• Severe respiratory and circulatory system diseases.
• Hematologic malignancies.
• Positive serological tests such as AIDS, hepatitis B virus, hepatitis C virus and syphilis （antigen or antibody）.
• Tumors.
• Genetic and metabolic diseases.

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (6)

• Pharoah PO, Platt MJ, Cooke T. The changing epidemiology of cerebral palsy. Arch Dis Child Fetal Neonatal Ed. 1996 Nov;75(3):F169-73. doi: 10.1136/fn.75.3.f169.

  PMID: 8976681 BACKGROUND

• Richards CL, Malouin F. Cerebral palsy: definition, assessment and rehabilitation. Handb Clin Neurol. 2013;111:183-95. doi: 10.1016/B978-0-444-52891-9.00018-X.

  PMID: 23622163 BACKGROUND

• Himmelmann K. Epidemiology of cerebral palsy. Handb Clin Neurol. 2013;111:163-7. doi: 10.1016/B978-0-444-52891-9.00015-4. No abstract available.

  PMID: 23622160 BACKGROUND

• Reddihough DS, Collins KJ. The epidemiology and causes of cerebral palsy. Aust J Physiother. 2003;49(1):7-12. doi: 10.1016/s0004-9514(14)60183-5.

  PMID: 12600249 BACKGROUND

• Rethlefsen SA, Ryan DD, Kay RM. Classification systems in cerebral palsy. Orthop Clin North Am. 2010 Oct;41(4):457-67. doi: 10.1016/j.ocl.2010.06.005.

  PMID: 20868878 BACKGROUND

• Lubis MU, Tjipta GD, Marbun MD, Saing B. Cerebral palsy. Paediatr Indones. 1990 Mar-Apr;30(3-4):65-70.

  PMID: 2075008 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yihua An, Doctor

  the General Hospital of Chinese People's Armed Police Forces

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 28, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 27, 2017

Record last verified: 2015-07

Locations

CN (1)