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

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 g

SUBMITTER: Bieri M 

PROVIDER: S-EPMC6958721 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature