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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

Primary Purpose

Critical Limb Ischemia (CLI)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PLX-PAD
Placebo
Sponsored by
Pluristem Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia (CLI)

Eligibility Criteria

45 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult male or female subjects between ages 45-99 years of age.
  2. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
  3. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has 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 lesions in the index leg stable for at least 2 weeks.
  6. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
  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 highly effective birth control method throughout the study.
  9. Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed .

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 revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
  5. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
  6. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
  7. Life expectancy of less than 6 months.
  8. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.
  9. Severe congestive heart failure symptoms (New York Heart Association [NYHA] class III-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.
  15. Subject on renal replacement therapy or planned to start renal replacement therapy within 3 months of first screening visit.
  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), unless in long-term follow-up phase.
  17. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor.
  18. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin.
  19. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine.
  20. Pulmonary disease requiring supplemental oxygen treatment on a daily basis.
  21. Active malignancy or history of malignancy within 5 years prior to study entry.
  22. In the opinion of the investigator, the subject is unsuitable for participating in the study.
  23. Chronic liver disease Child Pugh class B\C

Sites / Locations

  • UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868
  • Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor
  • Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817
  • Vascular Center,Department of Surgery,UC Davis Health,4860 Y street
  • University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location
  • Miami Cardiac and Vascular Institute Baptist Health South Florida
  • Tufts Medical Center (TMC) (Tufts-New England Medical Center)
  • Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North.
  • Holy Medical Center
  • Northwell Health Comprehensive Wound Healing Center
  • Mount Sinai St. Luke's hospital
  • Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza
  • Austin Heart Clinical Research
  • Department of Plastic Surgery ,Ut Southwestern Medical Center
  • UMHAT "Virgin Mary" EOOD,Clinic of Vascular Surgery
  • MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str.
  • UMHAT "St. Georgi" EAD,Clinic: Vascular Surgery and Angiology 66 "Peshtersko Shosse" Blvd., 8th floor, Hirurgicheski blok
  • UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str
  • UMHAT "Medica" Ruse Department of Vascular Surgery 35, "Riga", Str Post code: 7013 Ruse, Bulgaria
  • MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology
  • Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B "Nikola Vaptzarov" Blvd
  • UMHAT "St. Ekaterina" EAD, Departement of Vascular Surgery
  • Cevni ambulance
  • Angiologicka ambulance
  • Vseobecna Fakultni Nemocnice v Praze
  • Intitute of Clinical and Experimental Medicine
  • Krajska zdravotni a.s., Masarykova nemocnice o.z.
  • Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany
  • Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany
  • Universitats-Herzzentrum Freiburg
  • Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin
  • HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie
  • Universitätsklinikum Carl Gustav Carus
  • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
  • Asklepios Klinik St.Georg-Angiologische Ambulanz
  • Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany
  • Universitaetsklinikum Muenster
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Szent Imre Egyetemi Oktato Korhaz
  • Flor Ferenc County Hospital
  • B-A-Z County and University Teaching Hospital
  • Josa Andras Megyei Korhaz
  • Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)
  • Barzilai Medical Center
  • Blood Vessel Day Care at Clalit Community Horev Center, Horev Center
  • Vascular Surgery Department, Hadassah Ein Karem MC
  • Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492
  • The Cardiological Department, The Baruch Padeh Medical Center
  • Acibadem Sistina Hospital,Thoracic and Vascular Surgery
  • Re-Medika General Hospital,Cardiovascular Surgery
  • Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery
  • Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego,
  • Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol
  • Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust
  • Kings College Hospital
  • Department of Vascular Research, St George's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PLX-PAD

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to major amputation or death (AFS)

Secondary Outcome Measures

Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.
Time to major amputation of the index leg.
Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.
NRS measures the intensity or magnitude of sensations and subject feelings and the relative strength of attitudes and opinions about specific stimuli, on a scale of 0 to 10 with a score of zero denoting "no pain at all" and a score of 10 denoting "worst possible pain".
Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.
Time (days) from randomization to occurrence of death.

Full Information

First Posted
December 27, 2016
Last Updated
December 23, 2020
Sponsor
Pluristem Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03006770
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pluristem Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia (CLI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLX-PAD
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
PLX-PAD
Intervention Description
Local intramuscular (IM) injections of PLX-PAD in the index leg.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Local intramuscular (IM) injections of Placebo in the index leg.
Primary Outcome Measure Information:
Title
Time to major amputation or death (AFS)
Time Frame
Up to 36 months from enrollment
Secondary Outcome Measure Information:
Title
Time to first occurrence of any of the events (in index leg)-major amputation, revascularization due to worsening of CLI, All-cause mortality.
Time Frame
Up to 36 months from enrollment
Title
Time to major amputation of the index leg.
Time Frame
Up to 36 months from enrollment
Title
Change from baseline in ischemic pain as assessed by numerical rating scale (NRS) at 6 months.
Description
NRS measures the intensity or magnitude of sensations and subject feelings and the relative strength of attitudes and opinions about specific stimuli, on a scale of 0 to 10 with a score of zero denoting "no pain at all" and a score of 10 denoting "worst possible pain".
Time Frame
6 months from enrollment
Title
Proportion of subjects with complete healing of all ischemic lesions i.e., ulcers and necroses in the index leg at 12 months.
Time Frame
12 months from enrollment
Title
Time (days) from randomization to occurrence of death.
Time Frame
Up to 36 months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female subjects between ages 45-99 years of age. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5) Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI >1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg) Subject unsuitable for revascularization (by any method) in the index leg. Ischemic lesions in the index leg stable for at least 2 weeks. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation). 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. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study. Subject understood, agreed and provided informed consent. Patients must give written informed consent before any assessment is performed . Exclusion Criteria: Non-atherosclerotic PAD (e.g. Buerger's disease). CLI with major tissue loss (Rutherford Category 6) in either leg. Evidence of active infection (e.g., cellulitis, osteomyelitis). Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg. Life expectancy of less than 6 months. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening. Severe congestive heart failure symptoms (New York Heart Association [NYHA] class III-IV). Uncontrolled severe hypertension. Diabetes mellitus with HbA1c >10%. Current or history of proliferative retinopathy. Known Hepatitis B virus or Hepatitis C virus or acquired immunodeficiency syndrome (AIDS) infections. Subjects with international normalized ratio (INR) >2. Subject on renal replacement therapy or planned to start renal replacement therapy within 3 months of first screening visit. 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), unless in long-term follow-up phase. Use of hyperbaric oxygen therapy, prostanoids, spinal cord stimulation, lumbar sympathectomy, wound dressing containing cells or growth factors, or topical platelet derived growth factor. Known allergies to any of the following: DMSO, human serum albumin, bovine serum albumin. History of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with IV steroids/epinephrine. Pulmonary disease requiring supplemental oxygen treatment on a daily basis. Active malignancy or history of malignancy within 5 years prior to study entry. In the opinion of the investigator, the subject is unsuitable for participating in the study. Chronic liver disease Child Pugh class B\C
Facility Information:
Facility Name
UCI Medical Center 101 The City Drive S. Bldg 55 Rm 334 Orange, CA 92868
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Cedars Sinai Medical Center,LA,Beverly Hills,8536 Wilshire Boulevard, Third Floor
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Vascular Center ∣ Department of Surgery ∣ UC Davis Health 4860 Y street, Sacramento, CA suite #3400, 95817
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Vascular Center,Department of Surgery,UC Davis Health,4860 Y street
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami Leonard M.Miller School of Medicine (UMMSM)-UHealth Pulmonary and Critical Care Medicine-Rosenstiel Building Location
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1015
Country
United States
Facility Name
Miami Cardiac and Vascular Institute Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Tufts Medical Center (TMC) (Tufts-New England Medical Center)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Room S3-746, Dept of Surgery, UMASS Medical School, 55 Lake Ave North.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Holy Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Northwell Health Comprehensive Wound Healing Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai St. Luke's hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019-1147
Country
United States
Facility Name
Duke University Medical Center,Durham,2424 Erwin Road Hock Plaza
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Austin Heart Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Department of Plastic Surgery ,Ut Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9132
Country
United States
Facility Name
UMHAT "Virgin Mary" EOOD,Clinic of Vascular Surgery
City
Burgas
ZIP/Postal Code
8127
Country
Bulgaria
Facility Name
MHAT Sveti Nokolay Chudotvorets EOOD - Lom,Surgery Department,Address 2, Todor Kableshkov str.
City
Lom
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
UMHAT "St. Georgi" EAD,Clinic: Vascular Surgery and Angiology 66 "Peshtersko Shosse" Blvd., 8th floor, Hirurgicheski blok
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
UMBAL Kanev AD - Ruse,Department of Vascular Surgery Address: 2, Nezavisimost str
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
UMHAT "Medica" Ruse Department of Vascular Surgery 35, "Riga", Str Post code: 7013 Ruse, Bulgaria
City
Ruse
ZIP/Postal Code
7013
Country
Bulgaria
Facility Name
MHAT National Heart Hospital EAD,Clinic of Vascular Surgery and angiology
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Acibadem City Clinic MHAT Tokuda, Vascular Surgery and Angiology 51B "Nikola Vaptzarov" Blvd
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "St. Ekaterina" EAD, Departement of Vascular Surgery
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Cevni ambulance
City
Hodonín
ZIP/Postal Code
69501
Country
Czechia
Facility Name
Angiologicka ambulance
City
Ostrava Dubina
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Prague
ZIP/Postal Code
12802
Country
Czechia
Facility Name
Intitute of Clinical and Experimental Medicine
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Krajska zdravotni a.s., Masarykova nemocnice o.z.
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Klinik und Poliklinik für Angiologie Universitätsklinikum Leipzig AöR Liebigstr. 20 04103 Leipzig, Germany
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
Medinos Klinikum Sonneberg Abteilung für Kardiologie/Angiologie - Studienambulanz Neustadter Straße 61 96515 Sonneberg Germany
City
Sonneberg
State/Province
Thueringen
ZIP/Postal Code
96515
Country
Germany
Facility Name
Universitats-Herzzentrum Freiburg
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Charite Centrum fur Herz - Kreislauf - und Gefassmedizin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch, Klinik fur Angiologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Asklepios Klinik St.Georg-Angiologische Ambulanz
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Klinik Kösching Krankenhausstr. 19, 85092 Kösching Germany
City
Kösching
ZIP/Postal Code
85092
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
State/Province
Fejer
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Szent Imre Egyetemi Oktato Korhaz
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Flor Ferenc County Hospital
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
B-A-Z County and University Teaching Hospital
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Josa Andras Megyei Korhaz
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78100
Country
Israel
Facility Name
Blood Vessel Day Care at Clalit Community Horev Center, Horev Center
City
Haifa
ZIP/Postal Code
3434119
Country
Israel
Facility Name
Vascular Surgery Department, Hadassah Ein Karem MC
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Vascular Surgery Department Rabin Medical Center Beilinson Hospital, 39 Jabotinski St. Petah Tikva Israel 4941492
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Cardiological Department, The Baruch Padeh Medical Center
City
Poriyya 'Illit
ZIP/Postal Code
15208
Country
Israel
Facility Name
Acibadem Sistina Hospital,Thoracic and Vascular Surgery
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Re-Medika General Hospital,Cardiovascular Surgery
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Special Hospital for Surgical Diseases Zan Mitrev Clinic ,Cardiovascular Surgery
City
Skopje
ZIP/Postal Code
1000
Country
North Macedonia
Facility Name
Cathedra and Clinic of Vascular Surgery and Angiology-Klinika Chirurgii Naczyniowej i Angiologii
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu, Osrodek Badawczo-Rozwojowy,Intensywnego Nadzoru Kardlologleznego,
City
Wrocław
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Vascular Research Clinical Research Centre Beaufort Way Southmead Hospital Westbury on Trym Bristol
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Hull And East Yorkshire Women And Children's Hospital-Hull And East Yorkshire Hospitals Nhs Trust
City
Hull
ZIP/Postal Code
HU32JZ
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Department of Vascular Research, St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30686676
Citation
Norgren L, Weiss N, Nikol S, Hinchliffe RJ, Lantis JC, Patel MR, Reinecke H, Ofir R, Rosen Y, Peres D, Aberman Z. PLX-PAD Cell Treatment of Critical Limb Ischaemia: Rationale and Design of the PACE Trial. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):538-545. doi: 10.1016/j.ejvs.2018.11.008. Epub 2019 Jan 25.
Results Reference
derived

Learn more about this trial

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

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