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Status unknownNCT01832454BMCP2Updated Sep 17, 2014

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

A Phase 2/3 interventional study of Intra thecal inj of autologous MNC in Cerebral Palsy, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 3 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by Chaitanya Hospital, Pune · Phase 2/3 and Interventional

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
3 Years to 15 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • cerebral palsy stem cells [MNCS]
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's planned enrollment of 100 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Chaitanya Hospital, Pune is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Intra thecal inj of autologous MNC

    Intra thecal inj of autologous MNC

    Other: Intra thecal inj of autologous MNC

Interventions

  • OtherIntra thecal inj of autologous MNC

    Intra thecal inj of autologous MNC

06

What researchers measure

Primary outcomes

  1. Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.

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

    Time frame: 6 months

Secondary outcomes

  1. -Improvement in IQ by using Benit Kamat scale.

    -Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.

    Time frame: 6 Months

07

Study locations

1 of 1 sites recruiting
  • Chaitnany Hospital
    Pune, Maharashtra 411009, India
    • Sachin A Jamadar, D ORTHO · Contact · sac2751982@gmail.com · +918888788880
    • Dr, Anant E Bagul, MS · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01832454
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (CO-Investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Apr 16, 2013
Start date
Mar 2011
Primary completion
Nov 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Sep 17, 2014

Study contacts

Anant E Bagul, M.S.
principal investigator · chaitanya stem cell centre

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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