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

Prospective, randomized, open-labeled, parallel group clinical study to evaluate safety and efficacy of R-HSC-001 in patients with Spinal Cord Injury

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000613

Enrollment

Registered

2009-08-28

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- Spinal Cord Injury

Interventions

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

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
To evaluate efficacy of R-HSC-001 in patients with acute spinal cord injury Timepoint: 6, 12, 24 weeks	—

Secondary

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

Countries

India

Contacts

Public ContactDr Chandra Viswanathan

Reliance Life Sciences Pvt. Ltd.

chandra.viswanathan@ril.com02240678352

Outcome results

None listed

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