Rationale and design for PACE

Patients with intermittent claudication injected with ALDH bright cells

Emerson C. Perin, Michael Murphy, John P. Cooke, Lem Moyé, Timothy D. Henry, Judy Bettencourt, Amir Gahremanpour, Nicholas Leeper, R. David Anderson, William R. Hiatt, Joao A. Lima, Bharath Venkatesh, Shelly L. Sayre, Rachel W. Vojvodic, Doris A. Taylor, Ray F. Ebert, Alan T. Hirsch

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Peripheral artery disease (PAD) is recognized as a public health issue because of its prevalence, functional limitations, and increased risk of systemic ischemic events. Current treatments for claudication, the primary symptom in patients with PAD, have limitations. Cells identified using cytosolic enzyme aldehyde dehydrogenase (ALDH) may benefit patients with severe PAD but has not been studied in patients with claudication. PACE is a randomized, double-blind, placebo-controlled clinical trial conducted by the Cardiovascular Cell Therapy Research Network to assess the safety and efficacy of autologous bone marrow-derived ALDHbr cells delivered by direct intramuscular injections in 80 patients with symptom-limiting intermittent claudication. Eligible patients will have a significant stenosis or occlusion of infrainguinal arteries and a resting ankle-brachial index less than 0.90 and will be randomized 1:1 to cell or placebo treatment with a 1-year follow-up. The primary end points are the change in peak walking time and leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging at 6 months compared with baseline. The latter 3 measurements are new physiologic lower extremity tissue perfusion and PAD imaging-based end points that may help to quantify the biologic and mechanistic effects of cell therapy. This trial will collect important mechanistic and clinical information on the safety and efficacy of ALDHbr cells in patients with claudication and provide valuable insight into the utility of advanced magnetic resonance imaging end points.

Original languageEnglish
Pages (from-to)667-673.e2
JournalAmerican Heart Journal
Volume168
Issue number5
DOIs
StatePublished - Nov 1 2014

Fingerprint

Intermittent Claudication
Aldehyde Dehydrogenase
Peripheral Arterial Disease
Cell- and Tissue-Based Therapy
Perfusion
Placebos
Magnetic Resonance Imaging
Safety
Ankle Brachial Index
Intramuscular Injections
Controlled Clinical Trials
Walking
Lower Extremity
Leg
Anatomy
Pathologic Constriction
Public Health
Arteries
Bone Marrow
Muscles

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Perin, E. C., Murphy, M., Cooke, J. P., Moyé, L., Henry, T. D., Bettencourt, J., ... Hirsch, A. T. (2014). Rationale and design for PACE: Patients with intermittent claudication injected with ALDH bright cells. American Heart Journal, 168(5), 667-673.e2. https://doi.org/10.1016/j.ahj.2014.07.021

Rationale and design for PACE : Patients with intermittent claudication injected with ALDH bright cells. / Perin, Emerson C.; Murphy, Michael; Cooke, John P.; Moyé, Lem; Henry, Timothy D.; Bettencourt, Judy; Gahremanpour, Amir; Leeper, Nicholas; Anderson, R. David; Hiatt, William R.; Lima, Joao A.; Venkatesh, Bharath; Sayre, Shelly L.; Vojvodic, Rachel W.; Taylor, Doris A.; Ebert, Ray F.; Hirsch, Alan T.

In: American Heart Journal, Vol. 168, No. 5, 01.11.2014, p. 667-673.e2.

Research output: Contribution to journalArticle

Perin, EC, Murphy, M, Cooke, JP, Moyé, L, Henry, TD, Bettencourt, J, Gahremanpour, A, Leeper, N, Anderson, RD, Hiatt, WR, Lima, JA, Venkatesh, B, Sayre, SL, Vojvodic, RW, Taylor, DA, Ebert, RF & Hirsch, AT 2014, 'Rationale and design for PACE: Patients with intermittent claudication injected with ALDH bright cells', American Heart Journal, vol. 168, no. 5, pp. 667-673.e2. https://doi.org/10.1016/j.ahj.2014.07.021
Perin, Emerson C. ; Murphy, Michael ; Cooke, John P. ; Moyé, Lem ; Henry, Timothy D. ; Bettencourt, Judy ; Gahremanpour, Amir ; Leeper, Nicholas ; Anderson, R. David ; Hiatt, William R. ; Lima, Joao A. ; Venkatesh, Bharath ; Sayre, Shelly L. ; Vojvodic, Rachel W. ; Taylor, Doris A. ; Ebert, Ray F. ; Hirsch, Alan T. / Rationale and design for PACE : Patients with intermittent claudication injected with ALDH bright cells. In: American Heart Journal. 2014 ; Vol. 168, No. 5. pp. 667-673.e2.
@article{8b6529187d234b89b057cdd75c6900dd,
title = "Rationale and design for PACE: Patients with intermittent claudication injected with ALDH bright cells",
abstract = "Peripheral artery disease (PAD) is recognized as a public health issue because of its prevalence, functional limitations, and increased risk of systemic ischemic events. Current treatments for claudication, the primary symptom in patients with PAD, have limitations. Cells identified using cytosolic enzyme aldehyde dehydrogenase (ALDH) may benefit patients with severe PAD but has not been studied in patients with claudication. PACE is a randomized, double-blind, placebo-controlled clinical trial conducted by the Cardiovascular Cell Therapy Research Network to assess the safety and efficacy of autologous bone marrow-derived ALDHbr cells delivered by direct intramuscular injections in 80 patients with symptom-limiting intermittent claudication. Eligible patients will have a significant stenosis or occlusion of infrainguinal arteries and a resting ankle-brachial index less than 0.90 and will be randomized 1:1 to cell or placebo treatment with a 1-year follow-up. The primary end points are the change in peak walking time and leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging at 6 months compared with baseline. The latter 3 measurements are new physiologic lower extremity tissue perfusion and PAD imaging-based end points that may help to quantify the biologic and mechanistic effects of cell therapy. This trial will collect important mechanistic and clinical information on the safety and efficacy of ALDHbr cells in patients with claudication and provide valuable insight into the utility of advanced magnetic resonance imaging end points.",
author = "Perin, {Emerson C.} and Michael Murphy and Cooke, {John P.} and Lem Moy{\'e} and Henry, {Timothy D.} and Judy Bettencourt and Amir Gahremanpour and Nicholas Leeper and Anderson, {R. David} and Hiatt, {William R.} and Lima, {Joao A.} and Bharath Venkatesh and Sayre, {Shelly L.} and Vojvodic, {Rachel W.} and Taylor, {Doris A.} and Ebert, {Ray F.} and Hirsch, {Alan T.}",
year = "2014",
month = "11",
day = "1",
doi = "10.1016/j.ahj.2014.07.021",
language = "English",
volume = "168",
pages = "667--673.e2",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Rationale and design for PACE

T2 - Patients with intermittent claudication injected with ALDH bright cells

AU - Perin, Emerson C.

AU - Murphy, Michael

AU - Cooke, John P.

AU - Moyé, Lem

AU - Henry, Timothy D.

AU - Bettencourt, Judy

AU - Gahremanpour, Amir

AU - Leeper, Nicholas

AU - Anderson, R. David

AU - Hiatt, William R.

AU - Lima, Joao A.

AU - Venkatesh, Bharath

AU - Sayre, Shelly L.

AU - Vojvodic, Rachel W.

AU - Taylor, Doris A.

AU - Ebert, Ray F.

AU - Hirsch, Alan T.

PY - 2014/11/1

Y1 - 2014/11/1

N2 - Peripheral artery disease (PAD) is recognized as a public health issue because of its prevalence, functional limitations, and increased risk of systemic ischemic events. Current treatments for claudication, the primary symptom in patients with PAD, have limitations. Cells identified using cytosolic enzyme aldehyde dehydrogenase (ALDH) may benefit patients with severe PAD but has not been studied in patients with claudication. PACE is a randomized, double-blind, placebo-controlled clinical trial conducted by the Cardiovascular Cell Therapy Research Network to assess the safety and efficacy of autologous bone marrow-derived ALDHbr cells delivered by direct intramuscular injections in 80 patients with symptom-limiting intermittent claudication. Eligible patients will have a significant stenosis or occlusion of infrainguinal arteries and a resting ankle-brachial index less than 0.90 and will be randomized 1:1 to cell or placebo treatment with a 1-year follow-up. The primary end points are the change in peak walking time and leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging at 6 months compared with baseline. The latter 3 measurements are new physiologic lower extremity tissue perfusion and PAD imaging-based end points that may help to quantify the biologic and mechanistic effects of cell therapy. This trial will collect important mechanistic and clinical information on the safety and efficacy of ALDHbr cells in patients with claudication and provide valuable insight into the utility of advanced magnetic resonance imaging end points.

AB - Peripheral artery disease (PAD) is recognized as a public health issue because of its prevalence, functional limitations, and increased risk of systemic ischemic events. Current treatments for claudication, the primary symptom in patients with PAD, have limitations. Cells identified using cytosolic enzyme aldehyde dehydrogenase (ALDH) may benefit patients with severe PAD but has not been studied in patients with claudication. PACE is a randomized, double-blind, placebo-controlled clinical trial conducted by the Cardiovascular Cell Therapy Research Network to assess the safety and efficacy of autologous bone marrow-derived ALDHbr cells delivered by direct intramuscular injections in 80 patients with symptom-limiting intermittent claudication. Eligible patients will have a significant stenosis or occlusion of infrainguinal arteries and a resting ankle-brachial index less than 0.90 and will be randomized 1:1 to cell or placebo treatment with a 1-year follow-up. The primary end points are the change in peak walking time and leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging at 6 months compared with baseline. The latter 3 measurements are new physiologic lower extremity tissue perfusion and PAD imaging-based end points that may help to quantify the biologic and mechanistic effects of cell therapy. This trial will collect important mechanistic and clinical information on the safety and efficacy of ALDHbr cells in patients with claudication and provide valuable insight into the utility of advanced magnetic resonance imaging end points.

UR - http://www.scopus.com/inward/record.url?scp=84908332709&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908332709&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2014.07.021

DO - 10.1016/j.ahj.2014.07.021

M3 - Article

VL - 168

SP - 667-673.e2

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 5

ER -