Evidence map›Paper›PMID 27255774›Full record

Trial reportJournal of translational medicine2016

Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy.

K Comella, J Parcero, H Bansal, J Perez, J Lopez, A Agrawal, T Ichim

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of translational medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% 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.

NCT01502514 phase1withdrawnnot on this map

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Cardiovascular Effects of Intramyocardial and Intravenous Implantation of Autologous Adipose-Derived Stem Cells in Ischemic Congestive Heart Failure Patients

TypeinterventionalSponsorAgeless Regenerative InstituteRan2011 to 2015Enrolled0ConditionsIschemic Congestive Heart FailureArmsFat Harvesting and Implantation of Adipose Derived Stem Cells
NCT06705023 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure

TypeinterventionalSponsorRalf RothoerlRan2024 to 2025Enrolled36ConditionsMyocardial Injury, LV Dysfunction, Coronary Artery Disease, Heart FailureArmsUncultured, autologous, adipose-derived regenerative cells (UA-ADRCs), Continuation of patient's best guideline based medical treatment
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
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  15. Therapeutic Potential of Adipose Stem Cells.Advances in experimental medicine and biology · 2021
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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

7 authors at 2 institutions in 2 countries.

K ComellaUS Stem Cell, Inc, Sunrise, FL, USA. kcomella@us-stemcell.com.
J ParceroRegenerative Medicine Institute, Tijuana, Mexico.
H BansalConsultant Regenerative Medicine, Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital, Rudrapur, Uttarakhand, 263153, India.
J PerezRegenerative Medicine Institute, Tijuana, Mexico.
J LopezRegenerative Medicine Institute, Tijuana, Mexico.
A AgrawalConsultant Regenerative Medicine, Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital, Rudrapur, Uttarakhand, 263153, India.
T IchimRegenerative Medicine Institute, Tijuana, Mexico.
Regenerative Medicine Institute · MXU.S. Stem Cell (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue. The SVF contains a mixture of cells including ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population. We evaluated the safety and efficacy of administering SVF intra-myocardially into patients with chronic ischemic cardiomyopathy.

methodsA total of 28 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the akinetic myocardial scar region using a transendocardial delivery system (MyoCath(®)) in patients who had experienced a previous myocardial infarct. The subjects were then monitored for adverse events, ejection fraction via echocardiogram and six-minute walk test (6MWT) over a period of 6 months.

resultsThe average EF was 29 % at baseline and significantly increased to 35 % at both 3 and 6 months. Patients walked an average of 349 m at baseline and demonstrated a statistically significant improvement at 3 and 6 months' post treatment of more than 80 m.

conclusionsOverall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy. Trial registration NCT01502514 Name of registry: http://www.clinicaltrials.gov URL: https://www.clinicaltrials.gov/ct2/show/NCT01502514?term=adipose+cells+heart&rank=4 Date of registration: December 27, 2011 Date of enrollment: January 2012.

Indexed as

Adipose TissueAdultAgedAged, 80 and overDemographyFemaleHumansMaleMiddle AgedMyocardial IschemiaMyocardiumStroke VolumeStromal CellsTreatment OutcomeAdipose derived stromal/stem cells (ADSCs)Adipose tissueCell therapyConnective tissueIschemic cardiomyopathyStem cellsStromal vascular fraction (SVF)

Identifiers

PMID27255774
PMCPMC4890248
OpenAlexW2417091394

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.