Evidence map›Paper›PMID 31937310›Full record

ArticleJournal of translational medicine2020

Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction.

Mark Bieri, Elias Said, Gabrielle Antonini, Donald Dickerson, Jorge Tuma, Courtney E Bartlett, Amit N Patel, Alexander Gershman

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03699943 (Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT03699943 nacompletednot on this map

Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

TypeinterventionalSponsorCreative Medical Health, Inc.Ran2015 to 2019Enrolled40ConditionsErectile DysfunctionArmsCaverStem
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

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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

8 authors at 5 institutions in 2 countries.

Mark BieriRegenerative Health LLC, Las Cruces, NM, USA.
Elias SaidRegenerative Health LLC, Las Cruces, NM, USA.
Gabrielle AntoniniAnonini Urology, Rome, Italy.
Donald DickersonCreative Medical Health, San Diego, CA, USA.
Jorge TumaMonterrico Clinic & San Felipe Clinic, Lima, Peru.
Courtney E BartlettUniversity of Arizona, Tucson, AZ, USA.
Amit N PatelUniversity of Utah - Bioengineering, Salt Lake City, UT, USA. dallaspatel@gmail.com.
Alexander GershmanInstitute for Advanced Urology LLC/University of California Los Angeles, Los Angeles, CA, USA.
Centro Peruano de Estudios Sociales · PECreative Health Care Management · USUniversity of Arizona · USUniversity of California, Los Angeles · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBone marrow mononuclear cells have been successfully utilized for numerous regenerative purposes. In the current study, patients suffering from erectile dysfunction (ED) unresponsive to phosphodiesterase 5 inhibitors were administered autologous bone marrow concentrate delivered intracavernously utilizing a point of care FDA cleared medical device.

methodsA total of 40 patients were treated in the primary trial and 100 in the clinical registry, with the longest follow up of 12 months.

resultsMinimal treatment associated adverse effects where observed related to short term bruising at the site of harvest or injection. No long-term adverse events were noted related to the intervention. Mean improvements in IIEF-5 score were 2 in the Caverstem 1.0 low dose group, 3 in the high dose Caverstem 1.0 group and 9 in the Caverstem 2.0 group. Furthermore, improvements peaked by 3 months and maintained at 6 months follow-up.

conclusionThese data support the safety and efficacy of point of care, minimally to non-manipulated, non-expanded bone marrow concentrate for the treatment of ED. Trial registration Funded by Creative Medical Health, Inc.; Clinicaltrials.gov number: NCT03699943; https://clinicaltrials.gov/ct2/show/NCT03699943?term=caverstem&rank=1; initially registered December 12, 2015.

Indexed as

Erectile DysfunctionPhosphodiesterase 5 InhibitorsBone MarrowBone Marrow TransplantationHumansMaleRegistriesTreatment OutcomePhosphodiesterase 5 InhibitorsBoneDysfunctionErectileMarrow

Identifiers

PMID31937310
PMCPMC6958721
OpenAlexW3006838315

What OpenQuestion holds

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LicenceCC BY
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.