Skip to main content
Clinical Trials/CTRI/2013/10/004105
CTRI/2013/10/004105
Active, not recruiting
Phase 2

A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of stroke.

Arivind Bagul0 sites100 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Arivind Bagul
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Arivind Bagul

Eligibility Criteria

Inclusion Criteria

  • 1\.Should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hyper tension.
  • 2\.Willingness to undergo Autologous Stem Cell Therapy
  • 3\.Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
  • 4\.Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria

  • 1\.Patients with pre\-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
  • 2\.History of life threatening allergic or immune\-mediated reaction.
  • 3\. Haemodynamically unstable subjects.
  • 4\.Subjects suffering from peripheral muscular dystrophy.
  • 5\.Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
  • 6\.Positive test results for Hepatitis A and Hepatitis B or C.
  • 7\.Alcohol and / or drug abuse/ dependence.
  • 8\.Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine \> 1\.5 mg/dL.
  • 9\.Neurological disease caused by autoimmune or genetic cause.

Outcomes

Primary Outcomes

Not specified

Similar Trials