Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01834664

Ataxic Infantile Cerebral Palsy

UNKNOWN PHASE1/PHASE2

Cell Therapy as Treatment for Cerebral Palsy

NCT02241395

Cerebral Palsy

WITHDRAWN PHASE1

Stem Cell Therapy for Cerebral Palsy

NCT01978821

Cerebral Palsy

WITHDRAWN PHASE1

Outcomes of Stem Cells for Cerebral Palsy

NCT02569775

Cerebral Palsy

COMPLETED PHASE2

Outcomes of Stem Cells for Cerebral Palsy

NCT02574923

Cerebral Palsy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intra thecal inj of autologous MNC

Group Type OTHER

Intra thecal inj of autologous MNC

Intervention Type OTHER

Intra thecal inj of autologous MNC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intra thecal inj of autologous MNC

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
* Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
* 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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
* Hemodynamically unstable patients
* history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
* peripheral Muscular dystropy

Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes