Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-06-30

Brief Summary

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This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

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Detailed Description

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Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.

Conditions

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Ataxic Infantile Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STEM CELL

Transfer of autologous stem cell \[MNCs \]intrathecally

Group Type OTHER

stem cell (MNCs )

Intervention Type BIOLOGICAL

Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval

Interventions

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stem cell (MNCs )

Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval

Intervention Type BIOLOGICAL

Other Intervention Names

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Intra thecal autologous stem cell MNCs

Eligibility Criteria

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Inclusion Criteria

* Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
* Patient suffer from cerebral palsy due to prenatal and postnatal cause,
* Willing to undergoing Bone Marrow derived autologous stem cell therapy.
* Able to Comprehend and give written informed consent form for the study
* willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria

* History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
* Hemodynamically unstable patients
* history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
* peripheral Muscular dystrophy

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes