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

Phase 2

Conditions: Health Condition 1: null- Acute paraplegia

Registration Number: CTRI/2013/10/004099

Lead Sponsor: Chaitanya Vaidyakiya seva sanstha

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Should suffer from Acute 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

Study & Design

Study Type: Interventional

Study Design: Not specified

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 associationTimepoint: 6, 9 & 12 months

Secondary Outcome Measures