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Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
stem cell intrathecal injection
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy CD133 cells intrathecal injection

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) 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.

Children who have a metallic or electrical implants

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CD133 transplantation

Control

Arm Description

The patients with cerebral palsy that underwent CD133 transplantation.

The patients with cerebral palsy that underwent regular observation.

Outcomes

Primary Outcome Measures

motor dysfunction
Evaluation the motor dysfunction 6months after intrathecal injection.
sensory dysfunction
Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
unconsciousness
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
fever
Evaluation the symptom of infection like fever 48hours after cell transplantation.

Secondary Outcome Measures

motor improvement
Measure the improvement of motor system by GMFM66.
Balance improvement
Measure the balance improvement by BBS.
Spasm
Evaluation the improvement of spasm after stem cell transplantation.

Full Information

First Posted
December 25, 2012
Last Updated
April 24, 2014
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01763255
Brief Title
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
Official Title
The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.
Detailed Description
In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy CD133 cells intrathecal injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD133 transplantation
Arm Type
Experimental
Arm Description
The patients with cerebral palsy that underwent CD133 transplantation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients with cerebral palsy that underwent regular observation.
Intervention Type
Biological
Intervention Name(s)
stem cell intrathecal injection
Other Intervention Name(s)
Stem cell transplantation
Intervention Description
Intrathecal injection of Bone marrow derived CD133 cells
Primary Outcome Measure Information:
Title
motor dysfunction
Description
Evaluation the motor dysfunction 6months after intrathecal injection.
Time Frame
6months
Title
sensory dysfunction
Description
Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
Time Frame
6months
Title
unconsciousness
Description
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
Time Frame
48hours
Title
fever
Description
Evaluation the symptom of infection like fever 48hours after cell transplantation.
Time Frame
48hours
Secondary Outcome Measure Information:
Title
motor improvement
Description
Measure the improvement of motor system by GMFM66.
Time Frame
6months
Title
Balance improvement
Description
Measure the balance improvement by BBS.
Time Frame
6months
Title
Spasm
Description
Evaluation the improvement of spasm after stem cell transplantation.
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled Exclusion Criteria: Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) 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. Children who have a metallic or electrical implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, MD,PhD
Organizational Affiliation
Head of Royan department of degenerative medicine,Head of Royan celltherapy center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ali Reza Zali, MD
Organizational Affiliation
Head of Neurosurgery research center of Shahid Beheshti University
Official's Role
Study Director
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://Royaninstitute.org
Description
Related Info

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Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

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