Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

NCT01763255 | Completed Phase 1 DMC

• 1 other identifier: Royan-Nerve-003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy CD133 cells intrathecal injection

Outcome Measures

Primary Outcomes (4)

• motor dysfunction

  Evaluation the motor dysfunction 6months after intrathecal injection.

  6months

• sensory dysfunction

  Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.

  6months

• unconsciousness

  Evaluation the rate of unconsciousness during 48hours after cell transplantation.

  48hours

• fever

  Evaluation the symptom of infection like fever 48hours after cell transplantation.

  48hours

Secondary Outcomes (3)

• motor improvement

  6months

• Balance improvement

  6months

• Spasm

  6months

Study Arms (2)

CD133 transplantation

EXPERIMENTAL

The patients with cerebral palsy that underwent CD133 transplantation.

Biological: stem cell intrathecal injection

Control

NO INTERVENTION

The patients with cerebral palsy that underwent regular observation.

Interventions

stem cell intrathecal injection BIOLOGICAL

Intrathecal injection of Bone marrow derived CD133 cells

Also known as: Stem cell transplantation

CD133 transplantation

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Hamid Gourabi, PhD

  Head of Royan Institute

  STUDY CHAIR

• Nasser Aghdami, MD,PhD

  Head of Royan department of degenerative medicine,Head of Royan celltherapy center

  STUDY DIRECTOR

• Ali Reza Zali, MD

  Head of Neurosurgery research center of Shahid Beheshti University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2012
• First Posted: January 8, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2011-01

Locations

IR (1)