Evidence map›Paper›PMID 29395424›Full record

Trial reportJournal of vascular surgery2018

Rationale and design of the Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial investigating the therapeutic mechanism of mesenchymal stromal cells in the treatment of critical limb ischemia.

S Keisin Wang, Linden A Green, Natalie A Drucker, Raghu L Motaganahalli, Andres Fajardo, Michael P Murphy

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of vascular surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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  8. Bioengineering Cell Therapy for Treatment of Peripheral Artery Disease.Arteriosclerosis, thrombosis, and vascular biology · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

S Keisin WangDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind.
Linden A GreenDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind.
Natalie A DruckerDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind.
Raghu L MotaganahalliDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind.
Andres FajardoDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind.
Michael P MurphyDivision of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, and VA Center for Molecular and Cellular Therapeutics in Cardiovascular Disease, Indianapolis, Ind. Electronic address: mipmurph@iupui.edu.
Richard L. Roudebush VA Medical Center · US

Funding

Utility of Autologous and Allogeneic Cell Therapy for Peripheral Arterial DiseaseUM1HL113457 · NHLBI · INDIANA UNIVERSITY INDIANAPOLIS · PI MURPHY, MICHAEL PATRICK · 2012 to 2018
$3.0M
A Clinical and Histological Analysis of Mesenchymal Stem Cells in AmputationR01HL128827 · NHLBI · INDIANA UNIVERSITY INDIANAPOLIS · PI MURPHY, MICHAEL PATRICK · 2016 to 2019
$1.8M
NHLBI NIH HHS R01 HL128827NHLBI NIH HHS UM1 HL113457
6 · The paper itself

Abstract

objectiveCurrently, there are no accepted nonsurgical therapies that improve the delivery of blood-derived nutrients to patients with critical limb ischemia. Here, we describe the ongoing phase 1/2 Clinical and Histologic Analysis of Mesenchymal Stromal Cells in AmPutations (CHAMP) trial, which will provide crucial evidence of the safety profile of mesenchymal stromal cells (MSCs) and explore their therapeutic mechanisms in the setting of critical limb ischemia requiring below-knee amputation (BKA).

methodsIn the CHAMP and the parallel marrowCHAMP trials (hereafter grouped together as CHAMP), a total of 32 extremities with rest pain or tissue loss requiring BKA will be enrolled to receive intramuscular injections of allogeneic MSCs (CHAMP; n = 16) or autogenous concentrated bone marrow aspirate (marrowCHAMP; n = 16) along the distribution of the BKA myocutaneous flap and proximal tibialis anterior. After treatment, subjects are randomized to BKA at four time points after injection (days 3, 7, 14, and 21). At the time of amputation, skeletal muscle is collected at 2-cm increments from the tibialis injection site and used to determine proangiogenic cytokine description, MSC retention, quantification of proangiogenic hematopoietic progenitor cells, and histologic description. Clinical limb perfusion before and after treatment will be quantified using transcutaneous oximetry, toe-brachial index, ankle-brachial index, and indocyanine angiography. Additional clinical end points include all-cause mortality, need for amputation revision, and gangrene incidence during the 6-month post-treatment follow-up.

resultsEnrollment is under way, with 10 patients treated per protocol thus far. We anticipate full conclusion of follow-up within the next 24 months.

conclusionsCHAMP will be pivotal in characterizing the safety, efficacy, and, most important, therapeutic mechanism of allogeneic MSCs and autogenous concentrated bone marrow aspirate in ischemic skeletal muscle.

Indexed as

Amputation, SurgicalIschemiaMesenchymal Stem Cell TransplantationMuscle, SkeletalPeripheral Arterial DiseaseAdultAgedAged, 80 and overAngiogenic ProteinsCells, CulturedClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicCritical IllnessCytokinesFemaleHumansAngiogenic ProteinsCytokines

Identifiers

PMID29395424
PMCPMC6019117
OpenAlexW2787544881

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.