Evidence map›Paper›PMID 35067072›Full record

Trial reportCirculation. Cardiovascular interventions2022

Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction.

Timothy D Henry, C Noel Bairey Merz, Janet Wei, Michel T Corban, Odayme Quesada, Sandy Joung, Christine L Kotynski, Jian Wang, Michelle Lewis, Ann M Schumacher and 7 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation. Cardiovascular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03508609 (An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT03508609 phase2completednot on this map

An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease

TypeinterventionalSponsorLisata Therapeutics, Inc.Ran2018 to 2020Enrolled20ConditionsCoronary Microvascular DysfunctionArmsCLBS16
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  12. Current Evidence-Based Treatment of Angina With Nonobstructive Coronary Arteries (ANOCA).Journal of the Society for Cardiovascular Angiography & Interventions · 2025
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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

17 authors at 4 institutions in 1 country.

Timothy D HenryThe Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, OH (O.Q., T.D.H.).ORCID 0000-0003-1123-0533
C Noel Bairey MerzBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA (C.N.B.M., J.W., S.J.).ORCID 0000-0002-9933-5155
Janet WeiBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA (C.N.B.M., J.W., S.J.).ORCID 0000-0002-1311-618X
Michel T CorbanMayo Clinic, Rochester, MN (M.T.C., A.L.).
Odayme QuesadaThe Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, OH (O.Q., T.D.H.).
Sandy JoungBarbra Streisand Women's Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA (C.N.B.M., J.W., S.J.).ORCID 0000-0002-7582-3218
Christine L KotynskiCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Jian WangCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Michelle LewisCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Ann M SchumacherCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Ronnda L BartelCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Hiroshi TakagiCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Vishal ShahCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Anna LeeMayo Clinic, Rochester, MN (M.T.C., A.L.).
William K SietsemaCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).ORCID 0000-0003-1950-1692
Douglas W LosordoCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).
Amir LermanCaladrius Biosciences, Basking Ridge, NJ (C.L.K., J.W., M.L., A.M.S., R.L.B., H.T., V.S., A.L., W.K.S., D.W.L.).ORCID 0000-0002-9446-5313
L-3 Communications (United States) · USCedars-Sinai Smidt Heart Institute · USChrist Hospital · USMayo Clinic · US

Funding

The Microvascular Aging and Eicosanoids - Women's Evaluation of Systemic Aging Tenacity (MAE-WEST) ("You are never too old to become younger!") Specialized Center for Research Excellence (SCORE)U54AG065141 · NIA · CEDARS-SINAI MEDICAL CENTER · PI BAIREY MERZ, CATHLEEN NOEL, CHENG, SUSAN · 2020 to 2024
$8.7M
Exploratory Clinical Study To Evaluate The Potential Bioactivity Of CLBS16 In Patients With Coronary Microvascular DysfunctionR44HL135889 · NHLBI · LISATA THERAPEUTICS INC · PI LOSORDO, DOUGLAS W · 2017 to 2019
$1.9M
Hypertensive Disorders of Pregnancy: Pathways to Future Cardiovascular DiseaseK23HL151867 · NHLBI · THE CHRIST HOSPITAL · PI QUESADA, ODAYME · 2020 to 2024
$799k
NHLBI NIH HHS K23 HL151867NHLBI NIH HHS R44 HL135889NIA NIH HHS U54 AG065141
6 · The paper itself

Abstract

backgroundCoronary microvascular dysfunction results in angina and adverse outcomes in patients with evidence of ischemia and nonobstructive coronary artery disease; however, no specific therapy exists. CD34+ cell therapy increases microvasculature in preclinical models and improves symptoms, exercise tolerance, and mortality in refractory angina patients with obstructive coronary artery disease. The objective of this research was to evaluate the safety, tolerability, and efficacy of intracoronary CD34+ cell therapy in patients with coronary microvascular dysfunction.

methodsWe conducted a 2-center, 20-participant trial of autologous CD34+ cell therapy (protocol CLBS16-P01; NCT03508609) in patients with ischemia and nonobstructive coronary artery disease with persistent angina and coronary flow reserve ≤2.5. Efficacy measures included coronary flow reserve, angina frequency, Canadian Cardiovascular Society angina class, Seattle Angina Questionnaire, SF-36, and modified Bruce exercise treadmill test obtained at baseline and 6 months after treatment. Autologous CD34+ cells (CLBS16) were mobilized by administration of granulocyte-colony stimulating factor 5µg/kg/day for 5 days and collected by leukapheresis. Participants received a single intracoronary left anterior descending infusion of isolated CD34+ cells in medium that enhances cell function.

resultsCoronary flow reserve improved from 2.08±0.32 at baseline to 2.68±0.79 at 6 months after treatment (

conclusionsIn this pilot clinical trial of microvascular angina, patients with ischemia and nonobstructive coronary artery disease receiving intracoronary infusion of CD34+ cell therapy had higher coronary flow reserve, less severe angina, and better quality of life at 6 months. The current study supports a potential therapeutic role for CD34+ cells in patients with microvascular angina. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03508609.

Indexed as

Coronary Artery DiseaseMicrovascular AnginaMyocardial IschemiaAntigens, CD34CanadaCell- and Tissue-Based TherapyHumansIschemiaQuality of LifeTreatment OutcomeAntigens, CD34cell therapyexercise toleranceischemialeukapheresismicrovascular angina

Identifiers

PMID35067072
PMCPMC8843403
OpenAlexW4207047969

What OpenQuestion holds

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Registered trials

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.