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

Abstract

Background: Bone 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.

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

Results: Minimal 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.

Conclusion: These 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://ichgcp.net/clinical-trials-registry/NCT03699943?term=caverstem&rank=1; initially registered December 12, 2015.

Keywords: Bone; Dysfunction; Erectile; Marrow.

Conflict of interest statement

ANP and DD are a board members of Creative Medical Health. The authors declare that they have no competing interests.

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