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Intracavernous injection of stem cell-derived bioactive molecules for erectile dysfunction—a pilot phase non-randomized controlled trial

  • Ernst R von Schwarz1,2,3
  • Nathalie Busse1,4
  • Karen Mulholland Angelus1,4
  • Ahmed Omair2
  • Aubriana A von Schwarz1,2
  • Paul C Bogaardt1,4

1Heartstem, Inc., Beverly Hills, CA 90212, USA

2Southern California Hospital Heart Institute, Culver City, CA 90232, USA

3Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA

4Nustem, Inc., Beverly Hills, CA 90212, USA

DOI: 10.31083/jomh.2021.090 Vol.17,Issue 4,September 2021 pp.99-108

Submitted: 04 May 2021 Accepted: 23 May 2021

Published: 30 September 2021

*Corresponding Author(s): Ernst R von Schwarz E-mail: Dr.ernstschwarz@gmail.com

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Abstract

Background and objective: Experimental and few clinical studies have indicated great potential of stem cell treatments as both a causal and symptomatic approach for the treatment of male erectile dysfunction (ED). We investigated the effect of a one-time injection of stem-cell derived bioactive molecules in patients with self-reported ED.

Materials and methods: Twenty self-referred male patients with at least one-year history of ED received a one-time intra-penile injection of acellular stem cell-derived bioactive molecules. ED was evaluated by the International Index of Erectile Function questionnaire (IIEF-5), and quality of life was assessed by the Short-Form-36 questionnaire, (SF-36) at baseline and at 6 months. Six male patients with ED, who received a similar injection using saline served as a historic control. Primary outcome was erectile function as measured by IIEF-5 scores. Secondary outcomes were quality of life, assessed by SF-36 questionnaire.

Results: IIEF-5 scores improved from 12.9 ± 4.47 at baseline to 18 ± 3.37 at follow-up (p < 0.05). No significant difference of IIEF-5 scores were observed in the historic controls during the observation period (11 ± 2.53 at baseline vs 10.67 ± 3.5 at follow-up; p > 0.05). Patients, who received stem cell injections, demonstrated significantly enhanced IIEF-5 scores compared to the historic control (p < 0.05). Quality of life scores were significantly improved (role limitations due to physical health issues 56.25 ± 42.82 at baseline vs 68.75 ± 40.45 at follow-up, p < 0.05, energy 51.57 ± 19.33 at baseline vs 57.75 ± 12.3 at follow-up, p < 0.05, emotional wellbeing 56.32 ± 16.28 at baseline vs 68.1 ± 11.73 at follow-up, p < 0.05, and social functioning 67.5 ± 23.79 at baseline vs 76.25 ± 18.98 at follow-up, p < 0.05).

Conclusions: A one-time intracavernous acellular stem cell-derived bioactive molecule injection improves IIEF-5 scores and quality of life in men with ED in this small pilot phase study (ClinicalTrials.gov Identifier: NCT04684602).

Keywords

Erectile dysfunction; Stem cell therapy; Umbilical cord blood; Exosome; Secretome

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Ernst R von Schwarz,Nathalie Busse,Karen Mulholland Angelus,Ahmed Omair,Aubriana A von Schwarz,Paul C Bogaardt. Intracavernous injection of stem cell-derived bioactive molecules for erectile dysfunction—a pilot phase non-randomized controlled trial. Journal of Men's Health. 2021. 17(4);99-108.

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