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

Primary Purpose

Ataxic Infantile Cerebral Palsy

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
stem cell (MNCs )
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxic Infantile Cerebral Palsy focused on measuring Ataxic Infantile Cerebral Palsy stem cell therapy

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
  • Patient suffer from cerebral palsy due to prenatal and postnatal cause,
  • Willing to undergoing Bone Marrow derived autologous stem cell therapy.
  • 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,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
  • Hemodynamically unstable patients
  • history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
  • peripheral Muscular dystrophy

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEM CELL

Arm Description

Transfer of autologous stem cell [MNCs ]intrathecally

Outcomes

Primary Outcome Measures

Improvement in muscle rigidity using Ash worth scale

Secondary Outcome Measures

Improvement in dysregulated phospholipid Metabolism
Improvement in walking ability and kinetic gait Pattern
Improvement in overall motor control using oxford scale
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
Improvement in motor-linked implicit learning

Full Information

First Posted
April 8, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01834664
Brief Title
Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years
Acronym
BMACCP
Official Title
Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) .It is Self Funded (Patients' Own Funding) Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaitanya Hospital, Pune

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment 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 as per as various clinical scales and also changes in the brain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxic Infantile Cerebral Palsy
Keywords
Ataxic Infantile Cerebral Palsy stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEM CELL
Arm Type
Other
Arm Description
Transfer of autologous stem cell [MNCs ]intrathecally
Intervention Type
Biological
Intervention Name(s)
stem cell (MNCs )
Other Intervention Name(s)
Intra thecal autologous stem cell MNCs
Intervention Description
Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval
Primary Outcome Measure Information:
Title
Improvement in muscle rigidity using Ash worth scale
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Improvement in dysregulated phospholipid Metabolism
Time Frame
6 months
Title
Improvement in walking ability and kinetic gait Pattern
Time Frame
6 Months
Title
Improvement in overall motor control using oxford scale
Time Frame
6 Months
Title
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
Time Frame
6 month
Title
Improvement in motor-linked implicit learning
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI) Patient suffer from cerebral palsy due to prenatal and postnatal cause, Willing to undergoing Bone Marrow derived autologous stem cell therapy. 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,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction Hemodynamically unstable patients history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome peripheral Muscular dystrophy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin S Jamadar, Dortho
Phone
+918888788880
Email
sac2751982@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, M.S
Organizational Affiliation
CHAITANYA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaitanya Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin S Jamadar, MBBS.DOrtho
Phone
8888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Anant E Bagul, M.S.Ortho

12. IPD Sharing Statement

Learn more about this trial

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

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