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Completed

NCT Number: NCT01404663

Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD133 stem cell injection

Biological

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

Other names: stem cell transplantation

Primary outcomes

  1. allergic reaction

    Time frame: 1 month

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

  2. local infection

    Time frame: 1 month

    infections in site of injection

  3. encephalitis

    Time frame: 1 month

    encephalitis due to cell transplantation

  4. meningitis

    Time frame: 1 month

    meningitis due to cell trnsplantation

  5. paralysis or sensory loss

    Time frame: 6 months

    paralysis or sensory loss below the level of the injection site

Secondary outcomes

  1. speech

    Time frame: 6 months

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

  2. motion

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2011
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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