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Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years

Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832454
Acronym
BMCP2
Enrollment
100
Registered
2013-04-16
Start date
2011-03-31
Completion date
2015-12-31
Last updated
2014-09-17

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

Conditions

Cerebral Palsy

Keywords

cerebral palsy stem cells [MNCS]

Brief summary

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.

Detailed description

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

Interventions

OTHERIntra thecal inj of autologous MNC

Intra thecal inj of autologous MNC

Sponsors

Chaitanya Hospital, Pune
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.6 months\- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.

Secondary

MeasureTime frameDescription
-Improvement in IQ by using Benit Kamat scale.6 Months-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026