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History of Changes for Study: NCT03006770
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Latest version (submitted December 23, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 27, 2016 None (earliest Version on record)
2 February 13, 2017 Study Status, Oversight and Study Identification
3 April 24, 2017 Study Status and Outcome Measures
4 May 23, 2017 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 May 25, 2017 Contacts/Locations and Study Status
6 June 28, 2017 Study Status and Contacts/Locations
7 August 13, 2017 Study Status and Contacts/Locations
8 September 13, 2017 Study Status and Contacts/Locations
9 November 6, 2017 Study Status and Contacts/Locations
10 January 8, 2018 Contacts/Locations and Study Status
11 March 11, 2018 Contacts/Locations, Study Status and Eligibility
12 June 3, 2018 Contacts/Locations and Study Status
13 August 7, 2018 Contacts/Locations and Study Status
14 September 9, 2018 Contacts/Locations and Study Status
15 December 16, 2018 Contacts/Locations and Study Status
16 December 19, 2018 Contacts/Locations and Study Status
17 March 17, 2019 Contacts/Locations and Study Status
18 April 28, 2019 Contacts/Locations and Study Status
19 September 9, 2019 Contacts/Locations and Study Status
20 November 14, 2019 Contacts/Locations and Study Status
21 July 28, 2020 Study Status
22 August 18, 2020 Contacts/Locations and Study Status
23 December 6, 2020 Study Status, Eligibility and Outcome Measures
24 December 23, 2020 Recruitment Status, Study Status, Contacts/Locations, Study Design and Outcome Measures
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Study NCT03006770
Submitted Date:  December 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: PLX-CLI-03
Brief Title: Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Not yet recruiting
Study Start: February 2017
Primary Completion: February 2020 [Anticipated]
Study Completion:
First Submitted: December 27, 2016
First Submitted that
Met QC Criteria:
December 27, 2016
First Posted: December 30, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 27, 2016
Last Update Posted: December 30, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pluristem Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.
Detailed Description:
Open or close this module Conditions
Conditions: Critical Limb Ischemia (CLI)
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 246 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PLX-PAD
PLX-PAD will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
Biological: PLX-PAD
Local intramuscular (IM) injections of PLX-PAD in the index leg.
Placebo Comparator: Placebo
Placebo will be administered via 30 IM injections (0.5 mL each). Each subject will be treated twice, with an interval of 8 weeks between treatments.
Biological: Placebo
Local intramuscular (IM) injections of Placebo in the index leg.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Amputation Free Survival (AFS)
[ Time Frame: Up to 36 months from enrollment ]

Secondary Outcome Measures:
1. Time to first occurrence of any of the events (in index leg)-major amputation,revascularization due to worsening of CLI,doubling of total wound area from baseline,anew gangrene. All-cause mortality.
[ Time Frame: Up to 36 months from enrollment ]

2. Time to major amputation of the index leg.
[ Time Frame: Up to 36 months from enrollment ]

3. Complete wound healing in the index leg
[ Time Frame: 12 months from enrollment ]

4. Ischemic pain (NRS).
[ Time Frame: 6 months from enrollment ]

5. Time to adjudicated major amputation of the index leg or death
[ Time Frame: Up to 36 months from enrollment ]

Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Adult male or female subjects between ages 45-99 years of age.
  2. CLI, with minor tissue loss (Rutherford Category 5)
  3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. If a subject has both ABI >1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg.
  4. Subject unsuitable for revascularization (by any method) in the index leg .
  5. Ischemic wounds in the index leg stable for at least 2 weeks.
  6. Ischemic wounds in the index leg without tendon or bone exposure.
  7. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
  8. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one reliable form of birth control throughout the study.
  9. Signed informed consent form.

Exclusion Criteria:

  1. Non-atherosclerotic PAD (e.g. Buerger's disease).
  2. CLI with major tissue loss (Rutherford Category 6) in either leg.
  3. Evidence of active infection (e.g., cellulitis, osteomyelitis).
  4. Subject having undergone surgical/endovascular revascularization or major/minor amputation, less than 1 month prior to screening.
  5. Planned or potential need for major/minor amputation or any revascularization of within 1 month of study entry upon investigator's judgment.
  6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise inadequate inflow to the leg.
  7. Life expectancy of less than 6 months.
  8. Transient ischemic attack (TIA)/ stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
  9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] Stage IV).
  10. Uncontrolled severe hypertension.
  11. Diabetes mellitus with HbA1c >10%.
  12. Current or history of proliferative retinopathy.
  13. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections.
  14. Subjects with international normalized ratio (INR) >2.5.
  15. Subject on renal replacement therapy or with Creatinine Clearance <30 ml/min.
  16. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another investigational device or drug trial(s).
  17. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.
  18. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.
  19. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
  20. Active malignancy or history of malignancy within 5 years prior to study entry .
  21. In the opinion of the investigator, the subject is unsuitable for participating in the study.
  22. Inability to understand and provide an informed consent.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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