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Completed

NCT Number: NCT01763255

Multiple Transplantation of Bone Marrow Derived CD133 Cell 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 multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

stem cell intrathecal injection

Biological

Intrathecal injection of Bone marrow derived CD133 cells

Other names: Stem cell transplantation

Primary outcomes

  1. motor dysfunction

    Time frame: 6months

    Evaluation the motor dysfunction 6months after intrathecal injection.

  2. sensory dysfunction

    Time frame: 6months

    Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.

  3. unconsciousness

    Time frame: 48hours

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

  4. fever

    Time frame: 48hours

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

Secondary outcomes

  1. motor improvement

    Time frame: 6months

    Measure the improvement of motor system by GMFM66.

  2. Balance improvement

    Time frame: 6months

    Measure the balance improvement by BBS.

  3. Spasm

    Time frame: 6months

    Evaluation the improvement of spasm after stem cell transplantation.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2013
Registry last updated
Apr 25, 2014

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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