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A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. (BMACS)

Primary Purpose

Stroke,

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Intra thecal transplantation of Autologous Stem Cells
Sponsored by
Chaitanya Hospital, Pune
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke,

Eligibility Criteria

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

Inclusion Criteria:

  • Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
  • willingness to undergo bone marrow derived autologous cell therapy.
  • patient those provide fully Informed consent form for the study.
  • Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.

Exclusion Criteria:

  • Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
  • Alcohol and drug abuse / dependence.
  • Severe skin infection.
  • Haemodynamically unstable.
  • subject with primary and secondary diabetes , Insulin depenence,

Sites / Locations

  • Chaitanya HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transfer of autologous MNC intrathecally

Arm Description

Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.

Outcomes

Primary Outcome Measures

Improvement in power of Body and facial Muscles
Improvement in power of Body and facial Muscles.

Secondary Outcome Measures

Improvement in Walking Ability
Improvement in Walking Ability in 6 month.
Improvement In Speech and cognition
- Improvement In Speech and cognition ,Time period-6 month
Improvement in Vision in both eyes
Improvement in Vision in both eyes 6 month

Full Information

First Posted
April 9, 2013
Last Updated
September 16, 2014
Sponsor
Chaitanya Hospital, Pune
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1. Study Identification

Unique Protocol Identification Number
NCT01832428
Brief Title
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.
Acronym
BMACS
Official Title
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. 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
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
November 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, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
Detailed Description
This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke,

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transfer of autologous MNC intrathecally
Arm Type
Other
Arm Description
Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.
Intervention Type
Other
Intervention Name(s)
Intra thecal transplantation of Autologous Stem Cells
Intervention Description
Intra thecal transplantation of Autologous Stem Cells
Primary Outcome Measure Information:
Title
Improvement in power of Body and facial Muscles
Description
Improvement in power of Body and facial Muscles.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Improvement in Walking Ability
Description
Improvement in Walking Ability in 6 month.
Time Frame
6 months
Title
Improvement In Speech and cognition
Description
- Improvement In Speech and cognition ,Time period-6 month
Time Frame
6 Months
Title
Improvement in Vision in both eyes
Description
Improvement in Vision in both eyes 6 month
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension. willingness to undergo bone marrow derived autologous cell therapy. patient those provide fully Informed consent form for the study. Ability and willingness to regular visit to hospital and follow up during the protocol Procedure. Exclusion Criteria: Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction. Alcohol and drug abuse / dependence. Severe skin infection. Haemodynamically unstable. subject with primary and secondary diabetes , Insulin depenence,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin P 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 P Jamadar, Dortho
Phone
+918888788880
Email
sac2751982@gmail.com
First Name & Middle Initial & Last Name & Degree
Smita S Bhoyar, BAMS PGCR
Phone
+9372620569
Email
drsmitabhoyar@rediffmail.com
First Name & Middle Initial & Last Name & Degree
ANANT E BAGUL, MS

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.

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