Skip to main content

Critical Limb Ischemia

14
Pipeline Programs
30
Companies
45
Clinical Trials
5 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
1
6
1
4
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

30 companies ranked by most advanced pipeline stage

AnGes
AnGesJapan - Osaka
4 programs
1
2
HGF PlasmidPhase 31 trial
hepatocyte growth factor plasmidPhase 3
HGF PlasmidPhase 21 trial
Subjects from Study AG-CLI-0206 who received AMG0001N/A1 trial
Active Trials
NCT02974179Completed9Est. Jan 2020
NCT02016755Completed10Est. Mar 2018
NCT02144610Terminated46Est. Nov 2016
Boston Scientific
Boston ScientificCA - Valencia
3 programs
1
Drug Eluting Stent - Below the KneePhase 31 trial
Open surgical revascularizationN/A
care as usualN/A1 trial
Active Trials
NCT03171259Completed80Est. Dec 2023
NCT03551496Completed201Est. Dec 2023
Pfizer
PfizerNEW YORK, NY
1 program
1
ApixabanPhase 31 trial
Active Trials
NCT04229264Unknown200Est. May 2022
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
distal venous arterialisationPhase 2/31 trial
Active Trials
NCT01211925Unknown30Est. Jul 2011
Helixmith
HelixmithKorea - Seoul
2 programs
1
1
Low Dose VM202Phase 21 trial
VM202 2 mgPhase 11 trial
Active Trials
NCT00696124Completed12Est. Dec 2023
NCT01064440Completed52Est. Nov 2023
Hemostemix
HemostemixAB - Calgary
1 program
1
ACP-01Phase 21 trial
Active Trials
NCT02551679Completed67Est. Apr 2021
Lisata Therapeutics
Lisata TherapeuticsNJ - Basking Ridge
1 program
1
CLBS12Phase 21 trial
Active Trials
NCT02501018Completed33Est. May 2022
Design Pharmaceuticals
1 program
1
Mesenchymal stem cells from adipose tissuePhase 21 trial
Active Trials
NCT01745744Completed33Est. Jul 2018
Cytopeutics
CytopeuticsMalaysia - Cyberjaya
1 program
1
Mononuclear and mesenchymal stem cellsPhase 21 trial
Active Trials
NCT01456819Unknown50Est. Feb 2016
Innovation Pharmaceuticals
1 program
1
YQ23Phase 1/21 trial
Active Trials
NCT04792008Terminated5Est. Aug 2023
Biocorp
BiocorpFrance - Issoire
2 programs
1
Allogenic MSCPhase 11 trial
Autologous Adipose Tissue derived MSCs TransplantationN/A
Active Trials
NCT02336646Completed18Est. Dec 2018
LimFlow
LimFlowCA - San Jose
6 programs
LimFlow Stent Graft SystemN/A1 trial
LimFlow SystemN/A1 trial
LimFlow SystemN/A1 trial
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI StudyN/A1 trial
Percutaneous deep vein arterializationN/A1 trial
+1 more programs
Active Trials
NCT05313165Recruiting100Est. May 2027
NCT03124875Completed32Est. Jan 2021
NCT03970538Unknown105Est. Feb 2025
+3 more trials
Stempeutics Research
Stempeutics ResearchIndia - Bangalore
4 programs
mesenchymal stem cellsPHASE_1_21 trial
Allogeneic Mesenchymal Stem CellsPHASE_21 trial
Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cellsPHASE_41 trial
Stempeucel®PHASE_41 trial
Active Trials
NCT00883870Completed20Est. Aug 2012
NCT01484574Completed90Est. Mar 2016
NCT05854615Recruiting3Est. Dec 2027
+1 more trials
Philips
PhilipsNetherlands - Amsterdam
3 programs
Innovasc Tack Intravascular Staple SystemN/A1 trial
Stellarex DCBN/A1 trial
Tack-It Endovascular SystemN/A1 trial
Active Trials
NCT02044003Completed11Est. Dec 2011
NCT03175744Suspended82Est. Oct 2025
NCT02235675Completed35Est. Feb 2017
Reflow Medical
Reflow MedicalCA - San Clemente
2 programs
Below the Knee peripheral interventionN/A1 trial
Drug Eluting Temporary Spur Stent SystemN/A1 trial
Active Trials
NCT03669458Completed21Est. Jun 2019
NCT06122974Not Yet Recruiting518Est. Dec 2037
Medtronic
MedtronicNJ - Phillipsburg
2 programs
DCBN/A1 trial
Flowmet-DN/A1 trial
Active Trials
NCT02963649Completed50Est. Dec 2023
NCT05455554Unknown100Est. Sep 2023
Abbott
AbbottABBOTT PARK, IL
2 programs
Multidisciplinary Team Based Care ModelN/A1 trial
Open surgical revascularizationN/A1 trial
Active Trials
NCT04427124Unknown200Est. Dec 2023
NCT02060630Completed1,843Est. Mar 2022
United Therapeutics
United TherapeuticsMD - Silver Spring
2 programs
treprostinil dienthanolmine sustained releasePHASE_21 trial
Remodulin®PHASE_31 trial
Active Trials
NCT00651885Completed7Est. Dec 2010
NCT00060996Terminated30Est. Sep 2004
Temple Therapeutics
Temple TherapeuticsNetherlands - Geleen
1 program
ArtAssist© DeviceN/A1 trial
Active Trials
NCT02054416Unknown120Est. Feb 2019
R-Bio
R-BioTX - Houston
1 program
Autologous Adipose Tissue derived MSCs TransplantationN/A1 trial
Active Trials
NCT01663376Completed20Est. Apr 2011
Zimmer Biomet
Zimmer BiometFL - Jacksonville
1 program
Bone marrow concentration deviceN/A1 trial
Active Trials
NCT01049919Terminated153Est. Feb 2020
Artivion
ArtivionKENNESAW, GA
1 program
Cryopreserved Saphenous Vein AllograftN/A1 trial
Active Trials
NCT01799811Completed30Est. Jun 2016
REVA Medical
REVA MedicalCA - San Diego
1 program
MOTIV Sirolimus-Eluting Bioresorbable ScaffoldN/A1 trial
Active Trials
NCT05406622Recruiting292Est. Mar 2029
Cordis
CordisFL - Miami Lakes
1 program
Open surgical revascularizationN/A
Cagent Vascular
Cagent VascularPA - Wayne
1 program
Serranator PTA Serration CatheterN/A1 trial
Active Trials
NCT06434194Recruiting60Est. Jun 2025
Genesis Therapeutics
Genesis TherapeuticsCA - Burlingame
1 program
TGI SVF material via intramuscular injectionN/A
Tissue Genesis
Tissue GenesisTX - Leander
1 program
TGI SVF material via intramuscular injectionN/A1 trial
Active Trials
NCT02234778Unknown20Est. Oct 2023
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
Validation of OxyVu for Assessing Level of Amputation With Comparison to Other ModalitiesN/A1 trial
Active Trials
NCT00767923UnknownEst. Feb 2010
Design Therapeutics
1 program
Mesenchymal stem cells from adipose tissuePHASE_2
Vericel
VericelCAMBRIDGE, MA
1 program
Ixmyelocel-TPHASE_31 trial
Active Trials
NCT01483898Completed41Est. Mar 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Stempeutics ResearchStempeucel®
Stempeutics ResearchAdult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
PfizerApixaban
Boston ScientificDrug Eluting Stent - Below the Knee
AnGesHGF Plasmid
VericelIxmyelocel-T
United TherapeuticsRemodulin®
Angeles Therapeuticsdistal venous arterialisation
Lisata TherapeuticsCLBS12
HemostemixACP-01
AnGesHGF Plasmid
Stempeutics ResearchAllogeneic Mesenchymal Stem Cells
CytopeuticsMononuclear and mesenchymal stem cells
Design PharmaceuticalsMesenchymal stem cells from adipose tissue
HelixmithLow Dose VM202

Showing 15 of 45 trials with date data

Clinical Trials (45)

Total enrollment: 5,093 patients across 45 trials

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease

Start: Jan 2024Est. completion: Dec 202710 patients
Phase 4Recruiting
NCT05854615Stempeutics ResearchAdult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Start: Jan 2024Est. completion: Dec 20273 patients
Phase 4Recruiting

Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

Start: Jan 2020Est. completion: May 2022200 patients
Phase 3Unknown
NCT03551496Boston ScientificDrug Eluting Stent - Below the Knee

The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

Start: Aug 2018Est. completion: Dec 2023201 patients
Phase 3Completed
NCT02144610AnGesHGF Plasmid

Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia

Start: Nov 2014Est. completion: Nov 201646 patients
Phase 3Terminated
NCT01483898VericelIxmyelocel-T

An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

Start: Feb 2012Est. completion: Mar 201441 patients
Phase 3Completed

Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

Start: Feb 2003Est. completion: Sep 200430 patients
Phase 3Terminated
NCT01211925Angeles Therapeuticsdistal venous arterialisation

Distal Venous Arterialisation of Ischemic Limb

Start: Sep 2009Est. completion: Jul 201130 patients
Phase 2/3Unknown

Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)

Start: Nov 2017Est. completion: May 202233 patients
Phase 2Completed

ACP-01 in Patients With Critical Limb Ischemia

Start: Aug 2014Est. completion: Apr 202167 patients
Phase 2Completed
NCT02016755AnGesHGF Plasmid

A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

Start: Nov 2013Est. completion: Mar 201810 patients
Phase 2Completed
NCT01484574Stempeutics ResearchAllogeneic Mesenchymal Stem Cells

A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease

Start: Jan 2012Est. completion: Mar 201690 patients
Phase 2Completed
NCT01456819CytopeuticsMononuclear and mesenchymal stem cells

Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia

Start: Mar 2011Est. completion: Feb 201650 patients
Phase 2Unknown
NCT01745744Design PharmaceuticalsMesenchymal stem cells from adipose tissue

Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.

Start: Feb 2011Est. completion: Jul 201833 patients
Phase 2Completed
NCT01064440HelixmithLow Dose VM202

Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

Start: Jul 2010Est. completion: Nov 202352 patients
Phase 2Completed
NCT00651885United Therapeuticstreprostinil dienthanolmine sustained release

Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular Procedure

Start: Mar 2008Est. completion: Dec 20107 patients
Phase 2Completed

YQ23 Study in Patients With Critical Limb Ischaemia

Start: Mar 2021Est. completion: Aug 20235 patients
Phase 1/2Terminated
NCT00883870Stempeutics Researchmesenchymal stem cells

Mesenchymal Stem Cells in Critical Limb Ischemia

Start: Apr 2009Est. completion: Aug 201220 patients
Phase 1/2Completed
NCT02336646BiocorpAllogenic MSC

Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

Start: May 2015Est. completion: Dec 201818 patients
Phase 1Completed

Safety Study of Gene Therapy in Treating Critical Leg Ischemia

Start: Apr 2007Est. completion: Dec 202312 patients
Phase 1Completed
NCT06122974Reflow MedicalDrug Eluting Temporary Spur Stent System

Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia

Start: Aug 2026Est. completion: Dec 2037518 patients
N/ANot Yet Recruiting
NCT06434194Cagent VascularSerranator PTA Serration Catheter

Serrantor OCT Study

Start: Oct 2024Est. completion: Jun 202560 patients
N/ARecruiting
NCT05313165LimFlowLimFlow Stent Graft System

PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Start: Dec 2022Est. completion: May 2027100 patients
N/ARecruiting
NCT05406622REVA MedicalMOTIV Sirolimus-Eluting Bioresorbable Scaffold

MOTIV BTK Randomized Controlled Trial

Start: Jun 2022Est. completion: Mar 2029292 patients
N/ARecruiting

The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting

Start: Apr 2022Est. completion: Sep 2023100 patients
N/AUnknown
NCT04427124AbbottMultidisciplinary Team Based Care Model

The CLI-AMP Registry

Start: Aug 2020Est. completion: Dec 2023200 patients
N/AUnknown
NCT04304105LimFlowNatural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

Start: Feb 2020Est. completion: Sep 2022192 patients
N/ACompleted

SCOPE CLI (Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia)

Start: Jan 2020Est. completion: Dec 202380 patients
N/ACompleted
NCT03807661LimFlowPercutaneous deep vein arterialization

Percutaneous Deep Vein Arterialization Post-Market Study

Start: Dec 2019Est. completion: Oct 202428 patients
N/ACompleted
NCT03970538LimFlowLimFlow System

PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Start: Dec 2019Est. completion: Feb 2025105 patients
N/AUnknown
NCT03321552LimFlowPercutaneous deep vein arterialization

PROMISE International

Start: Dec 2017Est. completion: Jan 202534 patients
N/ACompleted
NCT03669458Reflow MedicalBelow the Knee peripheral intervention

Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.

Start: Oct 2017Est. completion: Jun 201921 patients
N/ACompleted
NCT03124875LimFlowLimFlow System

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Start: Jul 2017Est. completion: Jan 202132 patients
N/ACompleted
NCT03175744PhilipsStellarex DCB

Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Start: May 2017Est. completion: Oct 202582 patients
N/ASuspended

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Start: Mar 2017Est. completion: Dec 202350 patients
N/ACompleted
NCT02974179AnGesSubjects from Study AG-CLI-0206 who received AMG0001

A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

Start: Feb 2017Est. completion: Jan 20209 patients
N/ACompleted
NCT02234778Tissue GenesisTGI SVF material via intramuscular injection

Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia

Start: Aug 2014Est. completion: Oct 202320 patients
N/AUnknown
NCT02060630AbbottOpen surgical revascularization

Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Start: Aug 2014Est. completion: Mar 20221,843 patients
N/ACompleted
NCT02235675PhilipsTack-It Endovascular System

Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study

Start: Dec 2013Est. completion: Feb 201735 patients
N/ACompleted

External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality

Start: Oct 2013Est. completion: Feb 2019120 patients
N/AUnknown
NCT01799811ArtivionCryopreserved Saphenous Vein Allograft

Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization

Start: Feb 2013Est. completion: Jun 201630 patients
N/ACompleted
NCT01049919Zimmer BiometBone marrow concentration device

Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

Start: Jun 2010Est. completion: Feb 2020153 patients
N/ATerminated
NCT02044003PhilipsInnovasc Tack Intravascular Staple System

Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair

Start: Dec 2009Est. completion: Dec 201111 patients
N/ACompleted
NCT01663376R-BioAutologous Adipose Tissue derived MSCs Transplantation

Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cells Implantation in Patients With Critical Limb Ischemia

Start: Jan 2009Est. completion: Apr 201120 patients
N/ACompleted
NCT00767923T-TherapeuticsValidation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

Validation of OxyVu for Assessing Level of Amputation With Comparison to Other Modalities

Start: Jul 2008Est. completion: Feb 2010
N/AUnknown

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
5 actively recruiting trials targeting 5,093 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.