A Clinical Trial to study the safety & effectiveness of Adult Stem Cells derived from Bone Marrow via different routes of administration in the treatment of patients with complete Spinal Cord Injury (SCI)

Phase 2

• Registration Number: CTRI/2010/091/001469
• Lead Sponsor: Dr. Himanshu Bansal Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Be a Male/Female of ages 18 to 65 years
2. Who is properly informed of the nature and risks of the clinical study, who is willing and capable of complying with all clinical study procedures, and has given informed consent in writing prior to entering the clinical study. Subjects who are willing to comply with the study procedure.
3. Be with complete spinal cord injury (ASIA level A)
4. Time between injury and enrollment is greater than or equal 1 month and less than or equal to 1 year
5. Have Platelet count > 100 Thousand/µL at screening
6. Have White Blood Count < 15,000
7. International Normalized Ratio (INR) less than or equal to 1.5
8. Hematocrit < 30% prior to bone marrow aspiration
9. Have the neurological level is between C5 and T10
10. Have complete or partial transaction/damage as shown by MRI

Exclusion Criteria

x. Ongoing Alcohol/ Substance Abuse.
x. Intoxication, Intubation, Sedation and Immobilization
x.Osteoporosis or low bone mass as determined by medical history or DXA
x. Cancer over last 3 years prior to enrollment
x. Presence of a primary Hematological disease or any coagulation abnormalities or concomitant treatment with coumarin anti-coagulant
x. Implanted Medical Devices like Cardiac Stents, Pace Makers, Bladder Stimulators and Permanent modification of Anatomy
x. Uncontrolled Diabetes, Hypertension, Auto Immune Disease, Psychiatric illness, terminal Renal Failure with existing dependence on dialysis and history of Bone Marrow diseases
x. Possibility of non-compliance with the protocol.
x. Subjects with Syringomyelia, Spinal Stenosis, Plexopathy, Neuropathy, Radiculopathy, Cauda Equina Injury, Myelitis, Demyelination, Ischemia, Severe Spinal Degenerative Pathologies, Ongoing Focal Spinal Cord Compression or anatomically complete lesions
x.Longitudinal dimension of injury more than 3 segments
x. Women who is pregnant or nursing or of child-bearing potential unwilling to use effective barrier method of contraception for the duration of the study
x.No informed consent.
x. Signs of Meningitis with Fever (above 39°C)
x. Coma or other severe injury or disease
x. Penetrating injury
x. Unsuitable based on MRI or other factor
x. Subjects who have taken Immunosuppressant?s within the last one month

Study & Design

• Study Type: Interventional
• Study Design: Not specified