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 enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Arvind Bagul

•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.

•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.