Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404663
• Other study ID #: Royan-nerve-002
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2011
• Last updated: March 6, 2018
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Biological:
• CD133 stem cell injection
Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	allergic reaction	evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients	1 month
Primary	local infection	infections in site of injection	1 month
Primary	encephalitis	encephalitis due to cell transplantation	1 month
Primary	meningitis	meningitis due to cell trnsplantation	1 month
Primary	paralysis or sensory loss	paralysis or sensory loss below the level of the injection site	6 months
Secondary	speech	evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy	6 months
Secondary	motion	evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy	6 months

External Links

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