Evidence map›Paper›PMID 26217065›Full record

Trial reportStem cells translational medicine2015

REVIVE Trial: Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure.

Amit N Patel, Sanjay Mittal, Goekmen Turan, Amalia A Winters, Timothy D Henry, Hueseyin Ince, Naresh Trehan

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cells translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00130377 (Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease), which is not on this map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT00130377 phase2 / phase3unknown statusnot on this map

Biological Cell Therapy for the Treatment of Patients With Thoracic & Cardiovascular Disease

TypeinterventionalSponsorAmit N. Patel MD MSRan2002 to 2020Enrolled1,000ConditionsCardiovascular System Diseases (& [Cardiac])Armscell therapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Stem cell therapy for dilated cardiomyopathy.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
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 4 institutions in 3 countries.

Amit N PatelUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany amit.patel@hsc.utah.edu.
Sanjay MittalUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Goekmen TuranUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Amalia A WintersUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Timothy D HenryUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Hueseyin InceUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Naresh TrehanUniversity of Utah, Salt Lake City, Utah, USA; Heart Institute, Medanta MediCity, Gurgoan, India; Department of Cardiology, Rostock University Hospital, Rostock, Germany; Cedars-Sinai Heart Institute, Los Angeles, California, USA; Vivantes Klinikum, Berlin, Germany.
Medanta The Medicity · INUniversity of Utah · USUniversity of Rostock · DEVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledCell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy. Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure (IHF) or nonischemic heart failure (NIHF). This was a prospective randomized, multicenter, open-label study of the safety and feasibility of bone marrow aspirate concentrate (BMAC) infused retrograde into the coronary sinus. Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control (standard heart failure care) in a 4:1 ratio. Accordingly, 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group. Similarly, 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group. All 60 patients were successfully enrolled in the study. The treatment groups received BMAC infusion without complications. The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline, from 25.1% at screening to 31.1% at 12 months (p=.007) in the NIHF group and from 26.3% to 31.1% in the IHF group (p=.035). The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm (p=.020). Retrograde BMAC delivery is safe. All patients receiving BMAC experienced improvements in left ventricular ejection fraction, but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients. SIGNIFICANCE: This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure. This was a multinational, multicenter study, and it is novel, translatable, and scalable. On the basis of this trial and the safety of retrograde coronary sinus infusion, there are three other trials under way using this route of delivery.

Indexed as

Bone Marrow TransplantationAdultAgedBiomarkersBone MarrowCell- and Tissue-Based TherapyCoronary SinusFemaleHeart FailureHumansInfusions, IntravenousMaleMiddle AgedMyocardial IschemiaNatriuretic Peptide, BrainProspective StudiesBiomarkersNatriuretic Peptide, BrainCell transplantationCoronary sinusHeart failureRetrograde approach

Identifiers

PMID26217065
PMCPMC4542877
OpenAlexW1940760088

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.