Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01404663
First received: July 26, 2011
Last updated: March 13, 2013
Last verified: August 2010
  Purpose

Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.

In this study the investigators evaluate the side effect of bone marrow stem cell transplantation in patients with cerebral palsy.


Condition Intervention Phase
Cerebral Palsy
Biological: CD133 stem cell injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • allergic reaction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients

  • local infection [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    infections in site of injection

  • encephalitis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    encephalitis due to cell transplantation

  • meningitis [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    meningitis due to cell trnsplantation

  • paralysis or sensory loss [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    paralysis or sensory loss below the level of the injection site


Secondary Outcome Measures:
  • speech [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy

  • motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy


Enrollment: 12
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stem cell recipients
The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation
Biological: CD133 stem cell injection
Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
Other Name: stem cell transplantation

Detailed Description:

Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66).

After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of spastic quadriplegic CP
  2. Children must be between the ages of 4 and 12 years
  3. Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees)
  4. Children must be seizure-free or seizure controlled

Exclusion Criteria:

  1. Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
  2. Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.
  3. Children who have a metallic or electrical implants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404663

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Cell therapy Center
Principal Investigator: AliReza Zaali, MD Head of Research center of neurosurgery
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01404663     History of Changes
Other Study ID Numbers: Royan-nerve-002
Study First Received: July 26, 2011
Last Updated: March 13, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
bone marrow CD133 transplantation side effects
side effects

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014