The Effect of Intracavernosal Injection of Stem Cell in the Treatment of Erectile Dysfunction in Diabetic Patients; A Randomized Single-Blinded Clinical Trial Stem cell therapy for erectile dysfunction
23 February 2021
Purpose: The prevalence of erectile dysfunction in men is increasing. As well, the prevalence of diabetes, as one of the causes of sexual dysfunction, is rising in many countries. Due to the failure of common therapies in some patients with sexual dysfunction, it is necessary to develop an effective alternative treatment, such as stem cell therapy, for this problem.
Materials and Methods: In this randomized single-blinded clinical trial, 20 diabetic patients with erectile dysfunction, who were resistant to common treatments, were selected and divided into two groups of intervention and control (n=10 per group). Autologous mesenchymal stem cells (MSCs) were extracted from oral mucosa and then infused via intracavernosal injection (50-60 106 cells) to the participants of the intervention group. Normal saline was injected in the control group. The patients were followed up with the International Index of Erectile Function (IIEF5) questionnaire, as well as color Doppler duplex ultrasound. Peak systolic velocity (PSV), end diastolic velocity (EDV), and resistance index (RI) were determined at three and six months after the interventions.
Results: The mean IIEF5 scores in the intervention group were 7.2 ± 2.1, 9.2 ± 3.4, and 10.6 ± 4.7 before, three months, and six months after the injection, respectively, showing a significant ascending trend (p value = 0.01). Comparing the intervention and control groups, there was a significant difference in the IIEF5 score change during six months after the injection (p value = 0.02). Regarding the PSV and RI of penis vessels, there were no statistically significant differences between the two groups. However, these parameters showed upward and improving trends in the intervention group.
Conclusion: Intracavernosal injection of stem cells improved sexual function and PSV and RI indices of penile arteries in diabetic patients.
- Diabetes, Erectile dysfunction, Intracavernosal stem cell injection
How to Cite
2. Shamloul R, Ghanem H. Erectile dysfunction. The Lancet. 2013;381(9861):153-65.
3. Lue T. Physiology of penile erection and pathophysiology of erectile dysfunction and priapism. Campbell's urology. 1998:1157-79.
4. Mulhall JP, Bella AJ, Briganti A, McCullough A, Brock G. Erectile function rehabilitation in the radical prostatectomy patient. The journal of sexual medicine. 2010;7(4):1687-98.
5. Brant WO, Bella AJ, Lue TF. Treatment options for erectile dysfunction. Endocrinol Metab Clin North Am. 2007;36(2):465-79.
6. Peak TC, Anaissie J, Hellstrom WJ. Current perspectives on stem cell therapy for erectile dysfunction. Sexual Medicine Reviews. 2016;4(3):247-56.
7. Park JS, Suryaprakash S, Lao Y-H, Leong KW. Engineering mesenchymal stem cells for regenerative medicine and drug delivery. Methods. 2015;84:3-16.
8. Lin C-S. Advances in stem cell therapy for the lower urinary tract. World journal of stem cells. 2010;2(1):1.
9. Xin Z-C, Xu Y-D, Lin G, Lue TF, Guo Y-L. Recruiting endogenous stem cells: a novel therapeutic approach for erectile dysfunction. Asian journal of andrology. 2016;18(1):10.
10. Bahk JY, Jung JH, Han H, Min SK, Lee YS. Treatment of diabetic impotence with umbilical cord blood stem cell intracavernosal transplant: preliminary report of 7 cases. Exp Clin Transplant. 2010;8(2):150-60.
11. Cassini W, Zahalsky MP. Determining the feasibility of managing erectile dysfunction in humans with placental-derived stem cells. The Journal of the American Osteopathic Association. 2016;116(1):e1.
12. Yiou R, Hamidou L, Birebent B, Bitari D, Lecorvoisier P, Contremoulins I, et al. Safety of intracavernous bone marrow-mononuclear cells for postradical prostatectomy erectile dysfunction: an open dose-escalation pilot study. Eur Urol. 2016;69(6):988-91.
13. Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sørensen JA, et al. Safety and potential effect of a single intracavernous injection of autologous adipose-derived regenerative cells in patients with erectile dysfunction following radical prostatectomy: an open-label phase I clinical trial. EBioMedicine. 2016;5:204-10.
- Abstract Viewed: 0 times
- Just Accepted/6503 Downloaded: 0 times