NCT01404663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 7, 2018

Status Verified

August 1, 2010

Enrollment Period

6 months

First QC Date

July 26, 2011

Last Update Submit

March 6, 2018

Conditions

Cerebral Palsy

Keywords

bone marrow CD133 transplantation side effectsside effects

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • speech

    6 months

  • motion

    6 months

Study Arms (1)

stem cell recipients

EXPERIMENTAL

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

Biological: CD133 stem cell injection

Interventions

CD133 stem cell injectionBIOLOGICAL

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

Also known as: stem cell transplantation
stem cell recipients

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 25593079DERIVED

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan Institute

    STUDY CHAIR

  • Nasser Aghdami, MD,PhD

    Head of Cell therapy Center

    STUDY DIRECTOR

  • AliReza Zaali, MD

    Head of Research center of neurosurgery

    PRINCIPAL INVESTIGATOR

  • Leila Arab, MD

    Department of regenerative medicine,Royan Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 28, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

March 7, 2018

Record last verified: 2010-08

Locations

IR(1)