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

Stroke, Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832428
• Other study ID #: 00107
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 9, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, Dortho
• Phone: +918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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,

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke,

Intervention

Other:
• Intra thecal transplantation of Autologous Stem Cells
Intra thecal transplantation of Autologous Stem Cells

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in power of Body and facial Muscles	Improvement in power of Body and facial Muscles.	6 Months	Yes
Secondary	Improvement in Walking Ability	Improvement in Walking Ability in 6 month.	6 months	Yes
Secondary	Improvement In Speech and cognition	- Improvement In Speech and cognition ,Time period-6 month	6 Months	Yes
Secondary	Improvement in Vision in both eyes	Improvement in Vision in both eyes 6 month	6 month	Yes