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NCT03699943

Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

Completed NA Last updated 6 September 2019
What this trial tests

NA trial testing CaverStem in Erectile Dysfunction in 40 participants. Completed in 31 August 2019.

Timeline
8 December 2015
Primary endpoint
31 August 2018
31 August 2019

Quick facts

Lead sponsorCreative Medical Health, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingsingle
Primary purposetreatment
Enrollment40
Start date8 December 2015
Primary completion31 August 2018
Estimated completion31 August 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Creative Medical Health, Inc.

Who can join

Adults 18 to 85, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study assessed the safety and efficacy of autologous bone marrow concentrate and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment \>18 year old men, a demographic where the etiology of ED is attributable primarily to the loss of corporal smooth muscle in the penis. Study endpoints will evaluate the safety and efficacy of intracavernosal bone marrow concentrate administration for treating ED patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction.
    Bieri M, Said E, Antonini G, Dickerson D, et al · · 2020 · cited 11× · PMID 31937310 · DOI 10.1186/s12967-019-02195-w
  2. Autologous Immune Cell-Based Regenerative Therapies to Treat Vasculogenic Erectile Dysfunction: Is the Immuno-Centric Revolution Ready for the Prime Time?
    Bonanni M, Rehak L, Massaro G, Benedetto D, et al · · 2022 · cited 7× · PMID 35625828 · DOI 10.3390/biomedicines10051091
  3. Expert Consensus on Prevention and Treatment of Aging-Related Gonadal Dysfunction.
    Wang X, Ma L, Jiang S, Wen J, et al · · 2024 · cited 2× · PMID 38739936 · DOI 10.14336/ad.2024.0004

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Other recruiting trials for Erectile Dysfunction

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03699943.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing