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Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years

NCT01834664 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-09-17

No results posted yet for this study

Summary

This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Conditions

  • Ataxic Infantile Cerebral Palsy

Interventions

BIOLOGICAL

stem cell (MNCs )

Intra thecal transplantation of autologous stem cell \[MNCs \]Per dose at the interval

Sponsors & Collaborators

  • Chaitanya Hospital, Pune

    lead OTHER

Principal Investigators

  • ANANT E BAGUL, M.S · CHAITANYA HOSPITAL

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01834664 on ClinicalTrials.gov