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

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years. - BMCP2

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/10/004098
Enrollment
100
Registered
2013-10-25
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 below 15 years.

Interventions

Intervention1: Intra Thecal transplantation of Autologous Stem cells: 100 millions MNC per dose in 3 divided doses at interval of 10 days in total duration of 30 days Control Intervention1: NIL: NIL

Sponsors

Arvind Bagul
Lead Sponsor
Dr Anant Bagul
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy. 2. Regional nerve damage as shown by Magnetic Resonance Imaging (MRI) 3. Able to comprehend and give informed consent for the study and willing to come to the hospital for follow up visits as per the protocol requirements (patient or his legal guardian).

Exclusion criteria

Exclusion criteria: 1. History of meningitis, meningoencephalitis, epilepsy or life ?threatening allergic or immune-mediated reaction 2. Hemodynamically unstable patients 3. History of or concurrent autoimmune disease or an acute episode of Guillain-barre syndrome 4. Peripheral muscular dystrophy

Design outcomes

Primary

MeasureTime 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 weeks,3,6,9 months

Secondary

MeasureTime frame
Improvement in IQ by using Benit Kamat scale - Improvement in social behavior - Reduction in irritability. - Reduction in deformityTimepoint: 3,6,9&12 months

Countries

India

Contacts

Public ContactDr sachin jamadar

Chaitanya Hospital and NURSING HOME

anantbagul@yahoo.com08087799091

Outcome results

None listed

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