Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763255
• Other study ID #: Royan-Nerve-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 25, 2012
• Last updated: April 24, 2014
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: January 2011
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• stem cell intrathecal injection
Intrathecal injection of Bone marrow derived CD133 cells

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	motor dysfunction	Evaluation the motor dysfunction 6months after intrathecal injection.	6months	Yes
Primary	sensory dysfunction	Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.	6months	Yes
Primary	unconsciousness	Evaluation the rate of unconsciousness during 48hours after cell transplantation.	48hours	Yes
Primary	fever	Evaluation the symptom of infection like fever 48hours after cell transplantation.	48hours	Yes
Secondary	motor improvement	Measure the improvement of motor system by GMFM66.	6months	No
Secondary	Balance improvement	Measure the balance improvement by BBS.	6months	No
Secondary	Spasm	Evaluation the improvement of spasm after stem cell transplantation.	6months	No

External Links

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