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Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

CD133 stem cell injection

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring bone marrow CD133 transplantation side effects, side effects

Eligibility Criteria

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

Inclusion Criteria:

A 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 Type

Experimental

Arm Label

stem cell recipients

Arm Description

The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation

Outcomes

Primary Outcome Measures

allergic reaction

evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients

local infection

infections in site of injection

encephalitis

encephalitis due to cell transplantation

meningitis

meningitis due to cell trnsplantation

paralysis or sensory loss

paralysis or sensory loss below the level of the injection site

Secondary Outcome Measures

speech

evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy

motion

evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy

Full Information

NCT ID

NCT01404663

First Posted

July 26, 2011

Last Updated

March 6, 2018

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01404663

Brief Title

Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

May 2012 (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 bone marrow stem cell transplantation in patients with cerebral palsy.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

bone marrow CD133 transplantation side effects, side effects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stem cell recipients

Arm Type

Experimental

Arm Description

The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation

Intervention Type

Biological

Intervention Name(s)

CD133 stem cell injection

Other Intervention Name(s)

stem cell transplantation

Intervention Description

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

Primary Outcome Measure Information:

Title

allergic reaction

Description

evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients

Time Frame

1 month

Title

local infection

Description

infections in site of injection

Time Frame

1 month

Title

encephalitis

Description

encephalitis due to cell transplantation

Time Frame

1 month

Title

meningitis

Description

meningitis due to cell trnsplantation

Time Frame

1 month

Title

paralysis or sensory loss

Description

paralysis or sensory loss below the level of the injection site

Time Frame

6 months

Secondary Outcome Measure Information:

Title

speech

Description

evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy

Time Frame

6 months

Title

motion

Description

evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A 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 Cell therapy Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

AliReza Zaali, MD

Organizational Affiliation

Head of Research center of neurosurgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leila Arab, MD

Organizational Affiliation

Department of regenerative medicine,Royan Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25593079

Citation

Zali A, Arab L, Ashrafi F, Mardpour S, Niknejhadi M, Hedayati-Asl AA, Halimi-Asl A, Ommi D, Hosseini SE, Baharvand H, Aghdami N. Intrathecal injection of CD133-positive enriched bone marrow progenitor cells in children with cerebral palsy: feasibility and safety. Cytotherapy. 2015 Feb;17(2):232-41. doi: 10.1016/j.jcyt.2014.10.011. Epub 2014 Nov 1.

Results Reference

derived

Links:

URL

http://Royaninstitute.org

Description

Related Info

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