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

NCT ID: NCT01832428

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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

Conditions

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Stroke,

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transfer of autologous MNC intrathecally

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

Group Type OTHER

Intra thecal transplantation of Autologous Stem Cells

Intervention Type OTHER

Intra thecal transplantation of Autologous Stem Cells

Interventions

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Intra thecal transplantation of Autologous Stem Cells

Intra thecal transplantation of Autologous Stem Cells

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chaitanya Hospital, Pune

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sachin Jamadar

CO-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANANT E BAGUL, M.S

Role: PRINCIPAL_INVESTIGATOR

CHAITANYA HOSPITAL

Locations

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Chaitanya Hospital

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sachin P Jamadar, Dortho

Role: CONTACT

+918888788880

Facility Contacts

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Sachin P Jamadar, Dortho

Role: primary

+918888788880

Smita S Bhoyar, BAMS PGCR

Role: backup

+9372620569

Other Identifiers

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00107

Identifier Type: -

Identifier Source: org_study_id

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