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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)

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ClinicalTrials.gov Identifier: NCT01832428
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

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

Condition or disease Intervention/treatment Phase
Stroke, Other: Intra thecal transplantation of Autologous Stem Cells Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Transfer of autologous MNC intrathecally
Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.
Other: Intra thecal transplantation of Autologous Stem Cells
Intra thecal transplantation of Autologous Stem Cells




Primary Outcome Measures :
  1. Improvement in power of Body and facial Muscles [ Time Frame: 6 Months ]
    Improvement in power of Body and facial Muscles.


Secondary Outcome Measures :
  1. Improvement in Walking Ability [ Time Frame: 6 months ]
    Improvement in Walking Ability in 6 month.

  2. Improvement In Speech and cognition [ Time Frame: 6 Months ]
    - Improvement In Speech and cognition ,Time period-6 month

  3. Improvement in Vision in both eyes [ Time Frame: 6 month ]
    Improvement in Vision in both eyes 6 month



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832428


Contacts
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Contact: Sachin P Jamadar, Dortho +918888788880 sac2751982@gmail.com

Locations
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India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin P Jamadar, Dortho    +918888788880    sac2751982@gmail.com   
Contact: Smita S Bhoyar, BAMS PGCR    +9372620569    drsmitabhoyar@rediffmail.com   
Principal Investigator: ANANT E BAGUL, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL

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Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01832428     History of Changes
Other Study ID Numbers: 00107
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases