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

Phase 2/3

Active, not recruiting

Brief Summary: This study is a single arm, single center trial to check active comparing the safety and efficacy of Bone marrow derived autologous cells (100 million per dose). Trial to be conducted for 36 months in 100 patients with Chronic Paraplegia in India. Primary outcome measures are Improvement in overall sensory for motor control using Frankel score.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Improvement in overall sensory for motor control using Frankel score. - Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association)	6 weeks,3,6,9 months

Secondary Outcome Measures

Name	Time	Method
Improvement in bowel and bladder control	3,6,9 months

Locations (1): Chaitanya Hospital and Nursing Home
🇮🇳
Pune, MAHARASHTRA, India
Chaitanya Hospital and Nursing Home
🇮🇳Pune, MAHARASHTRA, India
Dr Anant bagul
Principal investigator
08087799091
anantbagul@yahoo.com