NCT01832454

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

4.7 years

First QC Date

February 26, 2013

Last Update Submit

September 16, 2014

Conditions

Cerebral Palsy

Keywords

cerebral palsy stem cells [MNCS]

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

  • -Improvement in IQ by using Benit Kamat scale.

    6 Months

Study Arms (1)

Intra thecal inj of autologous MNC

OTHER

Intra thecal inj of autologous MNC

Other: Intra thecal inj of autologous MNC

Interventions

Intra thecal inj of autologous MNCOTHER

Intra thecal inj of autologous MNC

Intra thecal inj of autologous MNC

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitnany Hospital

Pune, Maharashtra, 411009, India

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anant E Bagul, M.S.

    chaitanya stem cell centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CO-Investigator

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 16, 2013

Study Start

March 1, 2011

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)