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

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/10/004099

Enrollment

100

Registered

2013-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute paraplegia

Interventions

Intervention1: Intra Thecal transplantation of Autologous Stem cells: 100 millions MNC per dose in 3 divided doses at interval of 7 days in 30 days total duration of therapy will be 30 days Control In

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- Improvement in bowel and bladder control.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr sachin jamadar

Chaitanya Hospital and NURSING HOME

sachinjamadar82@gmail.com08087799091

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026