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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01832428
Acronym
BMACS
Enrollment
50
Registered
2013-04-16
Start date
2014-09-30
Completion date
2016-11-30
Last updated
2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke,

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

Interventions

OTHERIntra thecal transplantation of Autologous Stem Cells

Intra thecal transplantation of Autologous Stem Cells

Sponsors

Chaitanya Hospital, Pune
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
Improvement in power of Body and facial Muscles6 MonthsImprovement in power of Body and facial Muscles.

Secondary

MeasureTime frameDescription
Improvement in Walking Ability6 monthsImprovement in Walking Ability in 6 month.
Improvement In Speech and cognition6 Months\- Improvement In Speech and cognition ,Time period-6 month
Improvement in Vision in both eyes6 monthImprovement in Vision in both eyes 6 month

Countries

India

Contacts

Primary ContactSachin P Jamadar, Dortho
sac2751982@gmail.com+918888788880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026