A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects above 15 years.

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous stem cells for the treatment of cerebral palsy in subjects above 15 years.

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000159

Enrollment

100

Registered

2011-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cerebral Palsy above 15 years

Interventions

Intervention1: Stem cell therapy: Bone marrow derived Autologous cells - 100 millions per dose, total of 3 doses. Control Intervention1: Stem cell therapy: Bone marrow derived Autologous cells - 100 m

Eligibility

Inclusion criteria

Inclusion criteria: 1. Should suffer from cerebral palsy due to prenatal and postnatal cause. 2. Willingness to undergoing Bone marrow derived autologous stem cell therapy 3. Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study. 4. Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc. 2. History of life threatening allergic or immune-mediated reaction. 3. Haemodynamically unstable subjects. 4. Subjects suffering from peripheral muscular dystrophy. 5. Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure. 6. Positive test results for Hepatitis A and Hepatitis B or C. 7. Alcohol and / or drug abuse/ dependence. 8. Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL. 9. Neurological disease caused by autoimmune or genetic cause

Design outcomes

Primary

Measure	Time frame
Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale 3 monthsTimepoint: 6 months	—

Secondary

Measure	Time frame
Improvement in dysregulated phospholipid metabolism. - Improvement in orbito-frontal-amygdala circuit and self-regulation of social-emotional behavior.. - Improvement in motor-linked implicit learning. - Reduction in burden on familyTimepoint: 6 months	—

Countries

India

Contacts

Public ContactAnant Bagul

anantbagul@yahoo.com8087799091

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026