To Study the effect of PMZ-1620 in spinal cord injury patients.
- Conditions
- Health Condition 1: S141- Other and unspecified injuries ofcervical spinal cordHealth Condition 2: S241- Other and unspecified injuries ofthoracic spinal cordHealth Condition 3: S341- Other and unspecified injury of lumbar and sacral spinal cord
- Registration Number
- CTRI/2018/12/016667
- Lead Sponsor
- Pharmazz India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method