To study the safety and efficacy of R-HSC-001 (autologous stem cells) in patients with Spinal Cord Injury

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2009/091/000613
• Date of registration: 28-08-2009
• Prospective Registration: No
• Primary sponsor: Reliance Life Sciences Pvt Ltd
• Public title: To study the safety and efficacy of R-HSC-001 (autologous stem cells) in patients with Spinal Cord Injury
• Scientific title: Prospective, randomized, open-labeled, parallel group clinical study to evaluate safety and efficacy of R-HSC-001 in patients with Spinal Cord Injury
• Date of first enrolment: 07-10-2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=809
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Chandra Viswanathan
• Affiliation: Reliance Life Sciences Pvt. Ltd.

• Name: Dr Chandra Viswanathan
• Affiliation: Reliance Life Sciences Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Spinal Cord Injury

Intervention(s)

Intervention1: R-HSC-001: Administered before 6 weeks of spinal cord injury
Control Intervention1: Standard care of treatment: Medical care as per current guidelines

Primary Outcome(s)

To evaluate efficacy of R-HSC-001 in patients with acute spinal cord injury



Timepoint: 6, 12, 24 weeks

Secondary Outcome(s)

To evaluate the safety of R-HSC-001 in patients with acute spinal cord injuryTimepoint: 6,12,24 weeks

Secondary ID(s)

RLS/HSC/2007/02 Version 02, Dated: 19/11/08

Source(s) of Monetary Support

Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Center Thane Belapur Road, Rabale Navi Mumbai-400701, INDIA

Secondary Sponsor(s)

Applicable

Ethics review

Status: Approved
Approval date: 11/02/2009
Contact:

Ethics Committee, Pravara Institute of Medical Sciences, Loni

Status: Approved
Approval date: 28/05/2009
Contact:

Institutional Review Board, Chaitaniya Hospital

Status: Approved
Approval date: 20/06/2009
Contact:

Independent Ethics Committee RUs

Status: Approved
Approval date: 07/09/2009
Contact:

Ethics Committee of KLE university

Status: Approved
Approval date: 15/10/2009
Contact:

Institutional Ethics Comittee for Stem Cells Research & Therapy, LTM Medical College