Critical Limb Ischemia

11
Pipeline Programs
13
Companies
22
Clinical Trials
3 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

U
APIXABANApproved
apixaban
Unknown Company
oral

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Stempeutics Research
Stempeutics ResearchIndia - Bangalore
4 programs
1
1
2
Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cellsPhase 41 trial
Stempeucel®Phase 41 trial
Allogeneic Mesenchymal Stem CellsPhase 21 trial
mesenchymal stem cellsPhase 1/21 trial
Active Trials
NCT00883870CompletedEst. Aug 2012
NCT01484574CompletedEst. Mar 2016
NCT05854615RecruitingEst. Dec 2027
+1 more trials
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
Evolocumab 140mg/mL Injector 1milliliterPhase 41 trial
Active Trials
NCT04306471Unknown32Est. Feb 2022
United Therapeutics
United TherapeuticsMD - Silver Spring
2 programs
1
1
Remodulin®Phase 31 trial
treprostinil dienthanolmine sustained releasePhase 21 trial
Active Trials
NCT00651885Completed7Est. Dec 2010
NCT00060996Terminated30Est. Sep 2004
Pfizer
PfizerNEW YORK, NY
1 program
1
ApixabanPhase 31 trial
Active Trials
NCT04229264Unknown200Est. May 2022
Vericel
VericelCAMBRIDGE, MA
1 program
1
Ixmyelocel-TPhase 31 trial
Active Trials
NCT01483898Completed41Est. Mar 2014
Design Therapeutics
1 program
1
Mesenchymal stem cells from adipose tissuePhase 21 trial
Active Trials
NCT01745744CompletedEst. Jul 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
NCT05313165RecruitingEst. May 2027
NCT03124875CompletedEst. Jan 2021
NCT03970538UnknownEst. Feb 2025
+3 more trials
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
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
C
CordisFL - Miami Lakes
1 program
Open surgical revascularizationN/A
Genesis Therapeutics
Genesis TherapeuticsCA - Burlingame
1 program
TGI SVF material via intramuscular injectionN/A1 trial
Active Trials
NCT02234778UnknownEst. 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

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Stempeutics ResearchAdult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
Stempeutics ResearchStempeucel®
AmgenEvolocumab 140mg/mL Injector 1milliliter
PfizerApixaban
VericelIxmyelocel-T
United TherapeuticsRemodulin®
Stempeutics ResearchAllogeneic Mesenchymal Stem Cells
Design TherapeuticsMesenchymal stem cells from adipose tissue
United Therapeuticstreprostinil dienthanolmine sustained release
Stempeutics Researchmesenchymal stem cells
Reflow MedicalDrug Eluting Temporary Spur Stent System
LimFlowLimFlow Stent Graft System
AbbottMultidisciplinary Team Based Care Model
LimFlowNatural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study
LimFlowPercutaneous deep vein arterialization

Showing 15 of 22 trials with date data

Clinical Trials (22)

Total enrollment: 2,892 patients across 22 trials

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 2027
Phase 4Recruiting
NCT05854641Stempeutics ResearchStempeucel®

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

Start: Jan 2024Est. completion: Dec 2027
Phase 4Recruiting
NCT04306471AmgenEvolocumab 140mg/mL Injector 1milliliter

Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)

Start: Feb 2020Est. completion: Feb 202232 patients
Phase 4Unknown
NCT04229264PfizerApixaban

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

Start: Jan 2020Est. completion: May 2022200 patients
Phase 3Unknown
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
NCT00060996United TherapeuticsRemodulin®

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

Start: Feb 2003Est. completion: Sep 200430 patients
Phase 3Terminated
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 2016
Phase 2Completed
NCT01745744Design TherapeuticsMesenchymal 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 2018
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
NCT00883870Stempeutics Researchmesenchymal stem cells

Mesenchymal Stem Cells in Critical Limb Ischemia

Start: Apr 2009Est. completion: Aug 2012
Phase 1/2Completed
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
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 2027
N/ARecruiting
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 2022
N/ACompleted
NCT03807661LimFlowPercutaneous deep vein arterialization

Percutaneous Deep Vein Arterialization Post-Market Study

Start: Dec 2019Est. completion: Oct 2024
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 2025
N/AUnknown
NCT03321552LimFlowPercutaneous deep vein arterialization

PROMISE International

Start: Dec 2017Est. completion: Jan 2025
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 2021
N/ACompleted
NCT02234778Genesis TherapeuticsTGI SVF material via intramuscular injection

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

Start: Aug 2014Est. completion: Oct 2023
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
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

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 2,892 patients
13 companies competing in this space