A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.
BMACS
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 stroke
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedSeptember 17, 2014
September 1, 2014
2 years
April 9, 2013
September 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in power of Body and facial Muscles
Improvement in power of Body and facial Muscles.
6 Months
Secondary Outcomes (3)
Improvement in Walking Ability
6 months
Improvement In Speech and cognition
6 Months
Improvement in Vision in both eyes
6 month
Study Arms (1)
Transfer of autologous MNC intrathecally
OTHERIntra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.
Interventions
Intra thecal transplantation of Autologous Stem Cells
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaitanya Hospital
Pune, Maharashtra, 411009, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANANT E BAGUL, M.S
CHAITANYA HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CO-Investigator
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 16, 2013
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
September 17, 2014
Record last verified: 2014-09