Treatment for Acute Spinal Cord Injury using Sovateltide

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of PMZ-1620 (sovateltide) in patients with acute spinal cord injury. It is a multicentric, randomized, double-blind, parallel, saline-controlled Phase II study that compares the investigational drug with standard supportive care. The therapy aims to enhance neurogenesis and repair spinal cord damage by activating neuronal progenitor cells and promoting neurovascular repair. Participants will receive the treatment within 48 hours of injury and will be monitored for improvements in neurological function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult males or females aged between 18 and 75 years inclusive
2. Able to give consent for participation on their own or through their Legally Acceptable Representative (LAR)
3. Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (excludes patients who are on ventilator)
4. ISNCSCI Impairment Scale Grade "B," "C" or "D" based upon first ISNCSCI evaluation after arrival to the hospital is classified as motor or sensory incomplete
5. Willing and able to comply with the study Protocol
6. Women must be of non-childbearing potential or surgically sterile or willing to use adequate birth control; men who are sexually active will also be required to use adequate birth control
7. Able to receive the Investigational Drug within 48 hours of injury
8. Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon first ISNCSCI evaluation after arrival to the hospital
9. Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
10. Patients with any other chronic conditions, who are stable with appropriate treatment

Exclusion Criteria:

1. Previous history related to spinal cord disease
2. Patient on ventilator or requires ventilator
3. Patient with pathological fracture of vertebral column
4. Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified as complete injury
5. One or more upper extremity muscle groups un-testable during baseline ISNCSCI examination
6. Concomitant head injury with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
7. Females who are breastfeeding or have a positive urine pregnancy test
8. Body mass index (BMI) of ≥35 kg/m2 at screening
9. Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
10. Patient having rheumatoid arthritis
11. The participant has a clinically significant cardiovascular disorder or an abnormal electrocardiogram (ECG) at the discretion of the investigator
12. Pre-existent neurologic disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorder with hallucinations/delusions/schizophrenia)
13. Patients who are currently participating in a clinical trial with an investigational drug or investigational device
14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study

Where it's running

• Institute of Postgraduate Medical Education & Research and SSKM Hospital
  Kolkata, India Recruiting
• King George's Medical University
  Lucknow, India Recruiting
• Rahate Surgical Hospital & ICU
  Nagpur, India Recruiting
• Indian Spinal Injury Centre
  New Delhi, India Recruiting
• KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
  Belagavi, India Not yet recruiting

Study contacts

• Study coordinator: Manish S Lavhale
• Email: manish.lavhale@pharmazz.com
• Phone: +91 9873847397

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using ultrasound to improve treatment for acute spinal cord injury

  This study is testing if using special ultrasound during spinal surgery can help doctors see blood flow in patients with acute spinal cord injuries to improve their treatment and recovery.

  Recruiting Phase 4 University of Washington · Seattle, Washington · NCT06654804

• Improving cough in individuals with acute spinal cord injury using electrical stimulation and muscle training

  This study tests if using electrical stimulation and muscle training can help people with recent spinal cord injuries improve their ability to cough on their own.

  Recruiting University of Miami · Miami, Florida · NCT05745298

• Transcutaneous spinal stimulation to improve blood pressure after a recent spinal cord injury

  We will try a noninvasive spinal stimulation to see if it raises and steadies blood pressure in people 7–30 days after a thoracic spinal cord injury who have low blood pressure or dizziness when sitting up.

  Recruiting Kessler Foundation · West Orange, New Jersey · NCT05731986

• Using Glyburide to protect the spinal cord after injury

  This study is testing if giving the medication Glyburide soon after a spinal cord injury can help improve recovery for adults aged 18 to 80.

  Recruiting Phase 1 University of Kentucky · Lexington, Kentucky · NCT05426681

• Using Transcutaneous Spinal Cord Stimulation to stabilize blood pressure after spinal cord injury

  This study is testing whether a new method using Transcutaneous Spinal Cord Stimulation can help stabilize blood pressure in people with recent spinal cord injuries during their rehab.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT05305118

• Evaluating blood biomarkers for spinal cord injury recovery

  This study is testing whether certain blood markers can help doctors understand the severity of spinal cord injuries and predict how well patients will recover.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT05244408

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.