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Trial record 53 of 56 for:    stem cell Spinal Cord Injury AND cells

PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT04054414
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmazz, Inc.

Brief Summary:
This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: Normal Saline along with standard treatment Drug: PMZ-1620 along with standard treatment Phase 2

Detailed Description:

Trauma is projected to be third largest killer in the developing world by 2020, with a large number of these injuries comprising of traumatic spinal cord injury. People with spinal cord injuries (SCI) are two to five times more susceptible to die than people without an injury. More than 80% cases of SCIs occur among young people between the ages of 20 and 45 years and majority of sufferers are male. In developed countries, the incidence of spinal injuries varies from 20 to 50 per million. Every year about 250,000 to 500,000 number of SCI cases are reported.

There are hidden stem cells in the brain, which becomes active following injury to the spinal cord. Intravenous administration of PMZ-1620 (sovateltide) augments the activity of neuronal progenitor cells in the spinal cord to repair the damage by formation of new mature neurons and blood vessels. In addition, PMZ-1620 has anti-apoptotic and anti-oxidant activity.

Sovateltide is an endothelin B (ETB) receptor agonist (previously used names IRL-1620, SPI-1620 and PMZ-1620; International Non-proprietary Name (INN) approved by WHO is sovateltide). Activation of ETB receptors with PMZ-1620 produces neurovascular repair and remodeling or neuroregeneration.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).

In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.

In both treatment groups, subjects will be provided the best available standard of care.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicentric, Randomized, Double Blind, Saline Controlled Phase II Clinical Study to Compare the Safety and Efficacy of PMZ-1620 Therapy Along With Standard Supportive Care in Patients of Acute Spinal Cord Injury
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal Saline
Patients will receive the best available standard of care. In control group, 3 doses of equal volume of normal saline will be administered as an IV bolus over 1 minutes every 3 hours ± 1 hour on day 1, 3 and day 6 post randomization.
Drug: Normal Saline along with standard treatment
The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.
Other Name: Vehicle

Experimental: PMZ-1620
Patients will receive the best available standard of care. In PMZ group, 3 doses of PMZ-1620, at 0.3 μg/kg body weight will be administered as an intravenous bolus over 1 minute every 3 hours ± 1 hour on day 1, 3, and day 6 (total dose/day: 0.9 µg/kg body weight).
Drug: PMZ-1620 along with standard treatment
PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
Other Name: Sovateltide (IRL-1620) along with standard treatment




Primary Outcome Measures :
  1. Incidence of PMZ-1620 related adverse events [ Time Frame: 90 days ]
    The primary objective of the study is to determine incidence of drug (PMZ-1620) related adverse events.

  2. Number of patients not receiving full treatment [ Time Frame: 90 days ]
    Tolerability will be determined by the number of patients that do not receive all the 9 doses of PMZ-1620.


Secondary Outcome Measures :
  1. Changes in clinical progression of International Standards for Neurological Classification of spinal cord injury (ISNCSCI) [ Time Frame: 90 days ]
    Statistically relevant changes in clinical progression of ASCI as measured by ISNCSCI scoring at one, two and three months after treatment. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) or more commonly referred to as the ASIA Impairment Scale (AIS), is a universal classification tool for Spinal Cord Injury based on a standardized sensory and motor assessment. Ranges from A to E where A = Complete and no sensory or motor function is preserved and E = Normal sensory and motor functions

  2. Changes in walking index for spinal cord injury (WISCI) score [ Time Frame: 90 days ]
    Statistically relevant changes in WISCI Score at one, two and three months after treatment. This test assesses the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It rank orders the ability of a person to walk 10 meter after a spinal cord injury from most to least severe impairment. A score from 0 to 20 is assigned, level 0: patient is unable to stand and/or participate in walking and level 20 patient ambulates with no devices, with brace and no assistance.

  3. Changes in Spinal Cord Independence Measure (SCIM) score [ Time Frame: 90 days ]
    Statistically relevant changes in SCIM score at one, two and three months after treatment. Spinal Cord Independence Measure (SCIM) scale is used to measure the disability to specifically address the ability of SCI patients to perform basic activities of daily living independently. The SCIM scores range from 0 to 100 where where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.

  4. Changes in MRI/CT [ Time Frame: 90 days ]
    Changes in MRI/CT, before (baseline) and three months after treatment. Radiological evidence of transaction of spinal cord will be recorded by CT or MRI scan. In addition, edema, contusion, extent of spinal cord damage will be recorded.

  5. Changes in electromyography (EMG) [ Time Frame: 90 days ]
    Changes in EMG, before (baseline) and three months after treatment. Changes in nerve conduction parameters are recorded from the peroneal, tibial, and sural nerves. The presence of spontaneous activity (SA), including fibrillation and positive sharp waves are recorded in muscle groups vastus medialis, iliopsoas, tibialis anterior, medial gastrocnemius, and lumbar paraspinals. A decrease in nerve conduction parameters are indicative to greater severity. A high degree of abnormal SA on electromyographic testing represents the presence of muscle membrane instability.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054414


Contacts
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Contact: Manish S Lavhale +91 9873847397 manish.lavhale@pharmazz.com
Contact: Ravi Kant ravi.kant@pharmazz.com

Locations
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India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Not yet recruiting
Belgaum, India, 590010
Contact: Sameer Haveri    +91 9844333082    drsameerhaveri@gmail.com   
Institute of Postgraduate Medical Education & Research and SSKM Hospital Recruiting
Kolkata, India, 700020
Contact: Rajat Choudhuri    +91 9874660960    rajat.choudhuri@gmail.com   
King George's Medical University Recruiting
Lucknow, India, 226018
Contact: Shah Waliullah    +91-9335716350    shahwali2008@gmail.com   
Rahate Surgical Hospital & ICU Recruiting
Nagpur, India, 440008
Contact: Ravi P Dashputra    +91-9823079739    ravidash123@gmail.com   
Indian Spinal Injury Centre Recruiting
New Delhi, India, 110070
Contact: H.S. Chhabra    +91 11 42255356    drhschhabra@isiconline.org   
Sponsors and Collaborators
Pharmazz, Inc.
Investigators
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Study Chair: Anil Gulati Pharmazz, Inc.

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Responsible Party: Pharmazz, Inc.
ClinicalTrials.gov Identifier: NCT04054414     History of Changes
Other Study ID Numbers: PMZ-1620/CLINICAL-2.3/2017
CTRI/2018/12/016667 ( Registry Identifier: Clinical Trials Registry - India )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be communicated and published as manuscript

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharmazz, Inc.:
Endothelin
Neurogenesis
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System