Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Biological: CD133 stem cell injection

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
allergic reaction	evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients	1 month
local infection	infections in site of injection	1 month
encephalitis	encephalitis due to cell transplantation	1 month
meningitis	meningitis due to cell trnsplantation	1 month
paralysis or sensory loss	paralysis or sensory loss below the level of the injection site	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
speech	evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy	6 months
motion	evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy	6 months

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Nasser Aghdami, MD,PhD, Head of Cell therapy Center; Principal Investigator: AliReza Zaali, MD, Head of Research center of neurosurgery; Principal Investigator: Leila Arab, MD, Department of regenerative medicine,Royan Institute

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: side effects; bone marrow CD133 transplantation side effects
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Royan-nerve-002