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ACP-01 in Patients With Critical Limb Ischemia

Primary Purpose

Critical Limb Ischemia

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ACP-01

Placebo

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Stem cells, Autologous, Vascular disease, Peripheral arterial disease, Regenerative medicine, Amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is diagnosed with critical limb ischemia.
Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
Subject must be on standard of care medical therapy for peripheral vascular disease.
Male or female age 18 and above.
Non-pregnant, non-lactating female.
Subject is able to understand and provide voluntary signed informed consent.

Exclusion Criteria:

Uncorrected aorto-iliac occlusive disease.
Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
Lower extremity non-treated active infection.
Hypercoagulable state.
Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
Inability to communicate that may interfere with clinical evaluation.
Recent major non-vascular operation.
Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
Severe aortic stenosis.
Renal failure.
Hepatic failure.
Anemia.
Major stroke.
Diagnosis of malignancy.
Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
Bleeding diathesis.
Participation at the same time in another investigational product or device study.
Chronic cytotoxic drug treatment.
Life expectancy of less than 6 months.
Subject unlikely to be available for follow-up.
Acute worsening of CLI.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ACP-01

Placebo

Arm Description

Injection into lower extremity

Outcomes

Primary Outcome Measures

Wound Size, Amputation or Survival

Time to doubling of wound size, major amputation or death

Secondary Outcome Measures

Pain Level

Change in pain score according to the Visual Analog Scale for Pain.

Ulcer Size

Change in ulcer size

Full Information

NCT ID

NCT02551679

First Posted

September 14, 2015

Last Updated

January 27, 2020

Sponsor

Hemostemix

1. Study Identification

Unique Protocol Identification Number

NCT02551679

Brief Title

ACP-01 in Patients With Critical Limb Ischemia

Official Title

A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hemostemix

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.

Detailed Description

This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options. A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site. The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks. One futility analysis for potentially stopping study enrollment will be performed. Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving. The control group will receive placebo injections into the lower extremity to ensure blinding of the assessors and the subjects. The placebo will consist of the same medium used in the ACP product suspension. The study consists of four periods: Screening period, Treatment period, Acute safety follow-up and Long term follow-up periods. The total duration of study participation, including follow-up, is at least 26 weeks. Subjects will be followed for up to 52 weeks and at least until the last subject has completed his/her 26 week visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Limb Ischemia

Keywords

Stem cells, Autologous, Vascular disease, Peripheral arterial disease, Regenerative medicine, Amputation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ACP-01

Arm Type

Active Comparator

Arm Description

Injection into lower extremity

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Injection into lower extremity

Intervention Type

Biological

Intervention Name(s)

ACP-01

Intervention Description

Injection into lower extremity

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Injection into lower extremity

Primary Outcome Measure Information:

Title

Wound Size, Amputation or Survival

Description

Time to doubling of wound size, major amputation or death

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Pain Level

Description

Change in pain score according to the Visual Analog Scale for Pain.

Time Frame

1 year

Title

Ulcer Size

Description

Change in ulcer size

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Change from baseline in the dose and quantity of analgesic drugs used by the subject

Time Frame

1 - 52 wks

Title

Reduction in total hospitalization time of subjects treated with ACP-01 compared to subjects treated with placebo

Time Frame

1 - 52 wks

Title

Change from Baseline in Quality of Life

Description

Change in quality of life according to the Vascular Quality of Life Questionnaire.

Time Frame

1 - 52 wks

Title

Change from Baseline in Ankle Pressure

Time Frame

1 - 52 wks

Title

Change from Baseline in Toe Pressure

Time Frame

1 - 52 wks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is diagnosed with critical limb ischemia. Subject has hemodynamic indicators of severe peripheral arterial occlusive disease. Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease. Subject must be on standard of care medical therapy for peripheral vascular disease. Male or female age 18 and above. Non-pregnant, non-lactating female. Subject is able to understand and provide voluntary signed informed consent. Exclusion Criteria: Uncorrected aorto-iliac occlusive disease. Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo). Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene. Lower extremity non-treated active infection. Hypercoagulable state. Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood). Inability to communicate that may interfere with clinical evaluation. Recent major non-vascular operation. Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure. Severe aortic stenosis. Renal failure. Hepatic failure. Anemia. Major stroke. Diagnosis of malignancy. Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms. Severe concurrent disease (other than Peripheral Vascular Disease (PAD)). Bleeding diathesis. Participation at the same time in another investigational product or device study. Chronic cytotoxic drug treatment. Life expectancy of less than 6 months. Subject unlikely to be available for follow-up. Acute worsening of CLI.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alan Jacobs, MSEE MD PhD

regulatory@aspire2cure.com

Facility Information:

Facility Name

OrthoArizona

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Wallace

Phone

800-774-1534

r.wallace@prgresearch.com

First Name & Middle Initial & Last Name & Degree

Lewis Freed, DPM

Facility Name

UC Davis CTSC Clinical Research Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura B Jones

Phone

916-734-4156

lbjjones@ucdavis.edu

First Name & Middle Initial & Last Name & Degree

Matthew Mell, MD

Facility Name

Rocky Mountain Regional VA Medical Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Corbet

michele.corbet@cuanschutz.edu

First Name & Middle Initial & Last Name & Degree

Ehrin Armstrong, MD

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren Harvey, MSHS

Phone

352-273-5482

lmharvey@ufl.edu

First Name & Middle Initial & Last Name & Degree

Nancy Hanson

Phone

(352)273-5479

nancy.hanson@surgery.ufl.edu

First Name & Middle Initial & Last Name & Degree

Kristina Giles, MD

Facility Name

Clinovation Research, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandro Viloria

Phone

786-468-7425

alejandroviloria@clinovationresearch.com

First Name & Middle Initial & Last Name & Degree

Francisco Perez-Clavijo, DPM

First Name & Middle Initial & Last Name & Degree

Pablo Guala, MD

Facility Name

Clinical Research of Central Florida

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennel Smith, BS

Phone

863-853-5400

jsmith@clinicalresearchcf.com

First Name & Middle Initial & Last Name & Degree

Marty Fisher, BA

Phone

863-293-1191

Ext

3674

mfisher@clinicalresearchcf.com

First Name & Middle Initial & Last Name & Degree

Cary J Lambert, MD

Facility Name

Decatur Memorial Hospital

City

Decatur

State/Province

Illinois

ZIP/Postal Code

62526

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jade Becker

becker.jade@mhsil.com

First Name & Middle Initial & Last Name & Degree

Jeffrey Trachtenberg, MD

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Evans

Phone

708-216-1166

mevans11@luc.edu

First Name & Middle Initial & Last Name & Degree

Bernadette Aulivola, MD

Facility Name

University of Massachusetts Medical School

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shauneen Valliere

Phone

508-856-1767

shauneen.valliere@umassmed.edu

First Name & Middle Initial & Last Name & Degree

Andres Schanzer, MD

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tori Barker

Phone

603-650-6379

dorothy.h.barker@hitchcock.org

First Name & Middle Initial & Last Name & Degree

Philip Goodney, MD

Facility Name

Rutgers University New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Bott

Phone

973-972-3250

kb753@njms.rutgers.edu

First Name & Middle Initial & Last Name & Degree

Joe T Huang, MD

Facility Name

Moses H. Cone Memorial Hospital

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tammy Hedrick

Phone

336-832-3796

tammy.hedrick@conehealth.com

First Name & Middle Initial & Last Name & Degree

Vance W Brabham IV, MD

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rob Paris

Phone

336-716-3296

rparis@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Justin Hurie, MD

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Stout, RN

Phone

405-271-9060

Ext

44761

michael-h-stout@ouhsc.edu

First Name & Middle Initial & Last Name & Degree

Beau Hawkins, MD

Facility Name

Temple University Hosptial

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia McNelis

Phone

215-707-5187

patricia.mcnelis@tuhs.temple.edu

First Name & Middle Initial & Last Name & Degree

Eric Choi, MD

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caitlin Schaffner

Phone

843-793-7558

schaffne@musc.edu

First Name & Middle Initial & Last Name & Degree

Thomas E Brothers, MD

Facility Name

Houston Methodist DeBakey Heart & Vascular Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bevin Lopez, MS

Phone

713-441-6537

balopez@houstonmethodist.org

First Name & Middle Initial & Last Name & Degree

Eric Peden, MD

Facility Name

Clinical Trials of Texas, Inc. (CTT)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cynthia Ramos, BS

Phone

210-949-0122

Ext

177

cramos@cttexas.com

First Name & Middle Initial & Last Name & Degree

Boulos Toursarkissian, MD

Facility Name

Vancouver General Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1K3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lissette Araya, BSN

Phone

604 875-5077

lissette.araya@vch.ca

First Name & Middle Initial & Last Name & Degree

York Hsiang, MD

Facility Name

London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Teresa Novick

Phone

(519) 685-8500

Ext

75926

teresa.novick@lhsc.on.ca

First Name & Middle Initial & Last Name & Degree

Adam Power, MD

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Individual Site Status

Active, not recruiting

12. IPD Sharing Statement

Links:

URL

http://www.hemostemix.com

Description

Hemostemix Inc. website

Learn more about this trial

ACP-01 in Patients With Critical Limb Ischemia

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ACP-01 in Patients With Critical Limb Ischemia

Critical Limb Ischemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial