CTRI/2013/10/004109Active, not recruitingPhase 2
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of Chronic Paraplegia
Arvind Bagul0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Should suffer from Chronic Paraplegia due to pyramidal or extra-pyramidal cause.
- •Willingness to undergo Bone marrow derived Autologous cell therapy.
- •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.
- •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
- •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.
- •History of life threatening allergic or immune-mediated reaction.
- •Haemodynamically unstable subjects.
- •Subjects suffering from peripheral muscular dystrophy.
- •Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
- •Positive test results for Hepatitis A and Hepatitis B or C.
- •Alcohol and / or drug abuse/ dependence.
- •Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
- •Neurological disease caused by autoimmune or genetic cause.
Investigators
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