Phase
Condition
Spinal Cord Injuries
Treatment
Normal Saline along with standard treatment
PMZ-1620 along with standard treatment
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult males or females aged between 18 and 75 years inclusive
Able to give consent for participation on their own or through their LegallyAcceptable Representative (LAR)
Able to cooperate in the completion of a standardized neurological examination byISNCSCI standards (excludes patients who are on ventilator)
ISNCSCI Impairment Scale Grade "B," "C" or "D" based upon first ISNCSCI evaluationafter arrival to the hospital is classified as motor or sensory incomplete
Willing and able to comply with the study Protocol
Women must be of non-childbearing potential or surgically sterile or willing to useadequate birth control; men who are sexually active will also be required to useadequate birth control
Able to receive the Investigational Drug within 48 hours of injury
Neurological Level of Injury between C5-C8, T1-T12, L1-L5 and S1-S5 based upon firstISNCSCI evaluation after arrival to the hospital
Patient with incomplete/partial damage/transaction as shown by CT or MRI scan
Patients with any other chronic conditions, who are stable with appropriatetreatment
Exclusion
Exclusion Criteria:
Previous history related to spinal cord disease
Patient on ventilator or requires ventilator
Patient with pathological fracture of vertebral column
Impairment Scale Grade "A" based upon first ISNCSCI assessment and classified ascomplete injury
One or more upper extremity muscle groups un-testable during baseline ISNCSCIexamination
Concomitant head injury with a clinically significant abnormality on a head CT (headCT required only for patients suspected to have a brain injury at the discretion ofthe investigator)
Females who are breastfeeding or have a positive urine pregnancy test
Body mass index (BMI) of ≥35 kg/m2 at screening
Known immunodeficiency, including human immunodeficiency virus, or use ofimmunosuppressive or cancer chemotherapeutic drugs
Patient having rheumatoid arthritis
The participant has a clinically significant cardiovascular disorder or an abnormalelectrocardiogram (ECG) at the discretion of the investigator
Pre-existent neurologic disorder which would preclude accurate evaluation andfollow-up (i.e. Alzheimer's disease, Parkinson's disease, any psychiatric disorderwith hallucinations/delusions/schizophrenia)
Patients who are currently participating in a clinical trial with an investigationaldrug or investigational device
Patients who, in the opinion of the investigator, are otherwise unsuitable for thisstudy
Study Design
Study Description
Connect with a study center
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belgaum, 590010
IndiaSite Not Available
Institute of Postgraduate Medical Education & Research and SSKM Hospital
Kolkata, 700020
IndiaActive - Recruiting
King George's Medical University
Lucknow, 226018
IndiaActive - Recruiting
Rahate Surgical Hospital & ICU
Nagpur, 440008
IndiaActive - Recruiting
Indian Spinal Injury Centre
New Delhi, 110070
IndiaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.