Health Condition 1: S141- Other and unspecified injuries ofcervical spinal cord Health Condition 2: S241- Other and unspecified injuries ofthoracic spinal cord Health Condition 3: S341- Other and unspecified injury of lumbar and sacral spinal cord
Conditions
Sponsors
Pharmazz India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult males or females aged between 18 to 75 years, both inclusive 2. Able to give consent for participation on their own or through their Legally Authorized Representative (LAR) 3.Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards 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. Female subject is either: a. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation,bilateral oophorectomy or hysterectomy) or, b. If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, OR A vasectomised partner OR abstinence 7. Able to receive the Investigational Product 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
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 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. 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. 13. Patients who are currently participating in a clinical trial with an investigational product or investigational device 14. Patients who, in the opinion of the investigator, are otherwise unsuitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events (AEs) and serious adverse events (SAEs)Timepoint: 03 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI scoringTimepoint: From baseline to 1, 2 and 3 months after treatment;Statistically relevant changes in EMGTimepoint: From baseline and three months after treatment;Statistically relevant changes in MRI/CTTimepoint: From baseline and three months after treatment;Statistically relevant changes in SCIM scoreTimepoint: From baseline to 1, 2 and 3 months after treatment;Statistically relevant changes in WISCI II ScoreTimepoint: From baseline to 1, 2 and 3 months after treatment | — |
Countries
India
Contacts
Public ContactMr Sunil Gulati
Pharmazz India Private Limited
Outcome results
None listed