A Systematic Review of Human Trials Using Stem Cell Therapy for Erectile Dysfunction

Soum D. Lokeshwar, Premal Patel, Serena M. Shah, Ranjith Ramasamy

Research output: Contribution to journalReview article

Abstract

Introduction: Novel therapeutic modalities have been proposed for the treatment and management of erectile dysfunction (ED). Stem cell therapy (SCT) is the injection of mesenchymal stem cells or stromal vascular fractions from adipose and other tissue sources. Although SCT has been studied and reported in multiple rodent trials, few human clinical trials exist. Aim: The aim of this study was to provide a systematic review of SCT for the treatment of ED with an emphasis on data from peer-reviewed human studies. Methods: A systematic review was performed evaluating SCT for ED in human studies using PubMed-Medline and Scopus databases. Literature search was conducted using key words such as “Clinical Trials of SCT for ED,” “Stromal Vascular Fraction Treatment for ED,” and “SCT for ED.” Systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Main Outcome Measure: The main outcomes measure was the safety and efficacy of SCT for ED in humans. Results: 5 studies specific to SCT for ED treatment were included. A total of 61 patients were included in these phase I and II clinical trials and follow-up periods ranged from 6−62 months. End points of the studies included safety, tolerability, and efficacy of SCT for ED. The majority of the studies demonstrated improvement in erectile function due to SCT in patients, including improvements in penile vascular flow, International Index of Erectile Function-15 items, and Erectile Hardness Scale scores. All of the studies reported that there were no serious adverse events for patients. Limitations of the studies included small cohort sizes, and only 1 contained a sham arm. Conclusion: The 5 completed human clinical trials show promise for SCT as a restorative therapy for the treatment of ED. However, although promising, there still exists very limited data for the use of SCT for ED in humans. With the expansion of clinics offering SCT for ED, it is imperative that SCT is investigated further for safety, efficacy, and standardization. Lokeshwar SD, Patel P, Shah SM, et al. A Systematic Review of Human Trials using Stem Cell Therapy for Erectile Dysfunction. Sex Med Rev 2019;XX:XXX−XXX.

Original languageEnglish (US)
JournalSexual Medicine Reviews
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Erectile Dysfunction
Cell- and Tissue-Based Therapy
Stem Cells
Blood Vessels
Clinical Trials
Safety
Therapeutics
Outcome Assessment (Health Care)
Phase II Clinical Trials
Clinical Trials, Phase I
Hardness
Mesenchymal Stromal Cells
PubMed
Meta-Analysis
Adipose Tissue
Rodentia

Keywords

  • Erectile Dysfunction
  • Human Studies
  • Restorative Therapy
  • Stem Cell Therapy

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

Cite this

A Systematic Review of Human Trials Using Stem Cell Therapy for Erectile Dysfunction. / Lokeshwar, Soum D.; Patel, Premal; Shah, Serena M.; Ramasamy, Ranjith.

In: Sexual Medicine Reviews, 01.01.2019.

Research output: Contribution to journalReview article

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abstract = "Introduction: Novel therapeutic modalities have been proposed for the treatment and management of erectile dysfunction (ED). Stem cell therapy (SCT) is the injection of mesenchymal stem cells or stromal vascular fractions from adipose and other tissue sources. Although SCT has been studied and reported in multiple rodent trials, few human clinical trials exist. Aim: The aim of this study was to provide a systematic review of SCT for the treatment of ED with an emphasis on data from peer-reviewed human studies. Methods: A systematic review was performed evaluating SCT for ED in human studies using PubMed-Medline and Scopus databases. Literature search was conducted using key words such as “Clinical Trials of SCT for ED,” “Stromal Vascular Fraction Treatment for ED,” and “SCT for ED.” Systematic review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Main Outcome Measure: The main outcomes measure was the safety and efficacy of SCT for ED in humans. Results: 5 studies specific to SCT for ED treatment were included. A total of 61 patients were included in these phase I and II clinical trials and follow-up periods ranged from 6−62 months. End points of the studies included safety, tolerability, and efficacy of SCT for ED. The majority of the studies demonstrated improvement in erectile function due to SCT in patients, including improvements in penile vascular flow, International Index of Erectile Function-15 items, and Erectile Hardness Scale scores. All of the studies reported that there were no serious adverse events for patients. Limitations of the studies included small cohort sizes, and only 1 contained a sham arm. Conclusion: The 5 completed human clinical trials show promise for SCT as a restorative therapy for the treatment of ED. However, although promising, there still exists very limited data for the use of SCT for ED in humans. With the expansion of clinics offering SCT for ED, it is imperative that SCT is investigated further for safety, efficacy, and standardization. Lokeshwar SD, Patel P, Shah SM, et al. A Systematic Review of Human Trials using Stem Cell Therapy for Erectile Dysfunction. Sex Med Rev 2019;XX:XXX−XXX.",
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