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

Phase 1

• Conditions: Stroke,
• Interventions: Other: Intra thecal transplantation of Autologous Stem Cells

• Registration Number: NCT01832428
• Lead Sponsor: 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

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

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-09
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transfer of autologous MNC intrathecally	Intra thecal transplantation of Autologous Stem Cells	Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.

Primary Outcome Measures

Name	Time	Method
Improvement in power of Body and facial Muscles	6 Months	Improvement in power of Body and facial Muscles.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India