UnknownPhase 1/2

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

India100 participantsStarted 2013-03

Plain-language summary

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.

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in muscle rigidity using Ash worth scale

Timeframe: 6 Months

Trial details

NCT IDNCT01834664

SponsorChaitanya Hospital, Pune

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

Contact for this trial

Sachin S Jamadar, Dortho

+918888788880 sac2751982@gmail.com

View on ClinicalTrials.gov More Ataxic Infantile Cerebral Palsy trials