To study the safety and efficacy of R-HSC-001 (autologous stem cells) in patients with Spinal Cord Injury
- Conditions
- Health Condition 1: null- Spinal Cord Injury
- Registration Number
- CTRI/2009/091/000613
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Patients of ages more than 18 and less than 70 years (18 and 70 years inclusive)
2. Patients with acute thoracic (T2 to T12) or cervical spinal cord injury (C1-T1) and Frankel score of at least B. Patients with complete or partial transaction/damage as shown by MRI.
1. Significant head trauma or any other injury which in the opinion of the investigator, is sufficient to interfere with the assessment of spinal cord function or otherwise compromise the validity of the patient?s data
2.Hemodynamically unstable patients
3.History of or concurrent autoimmune disease or an acute episode of Guillain-Barre syndrome
4.AST/ALT of 2.5 X upper limit of normal and Serum Creatinine 2 X upper limit of normal
5.Severe skin infection and osteomyelitis /or at the site of bone marrow aspiration potentially limiting the procedure
6.Presence of a primary hematological disease or any coagulation abnormalities or concomitant treatment with coumarin anti-coagulant
7.Women of child-bearing potential unwilling to use effective barrier method of contraception for the duration of the study
16.Alcohol and/or drug abuse/dependency
17.Pregnant or nursing women
18.Any condition that in the judgment of the investigator would place the patient at undue risk
19.History of receiving an investigational product within 30 days prior to enrollment in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method