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

C

Chaitanya Hospital, Pune

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Stroke,

Treatments

Other: Intra thecal transplantation of Autologous Stem Cells

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Sachin P Jamadar, Dortho

Data sourced from clinicaltrials.gov

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