Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

NCT04396795 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20200373
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving MCID in IIEF-EF.

  Minimal clinically important difference (MCID) is measured by the number of participants who have achieved an increase in International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) based on their Erectile Dysfunction (ED) severity at baseline (an increase of 2 points from baseline for participants with mild ED and an increase of 5 points for participants with moderate ED). MCID in IIEF-EF scores are used to determine treatment efficacy of PRP compared to placebo. IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. This outcome is reported as the number of participants who achieve MCID in each treatment group.

  1 month, 3 month, 6 month

Secondary Outcomes (4)

• Change in IIEF-EF Scores

  Baseline up to Month 1, Month 3, and Month 6

• Change in Doppler Ultrasound Parameters - Peak Systolic Velocity (PSV)

  Baseline to Month 6

• Number of Adverse Events

  24 weeks

• Number of Participants With an End Diastolic Velocity (EDV) Value Greater Than 0, as Assessed by Penile Doppler Ultrasound at Baseline and Month 6.

  Baseline and Month 6

Study Arms (2)

PRP group

EXPERIMENTAL

Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days

Drug: Autologous Platelet Rich Plasma

Placebo group

PLACEBO COMPARATOR

Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.

Other: Saline solution

Interventions

Autologous Platelet Rich Plasma DRUG

Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum.

Also known as: PRP

PRP group

Saline solution OTHER

Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

Placebo group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be Male
• Be 30 to 75 years of age (inclusive).
• Be able to provide written informed consent.
• Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
• Sexually active in a stable, heterosexual relationship of more than three months duration.
• IIEF-EF score 11-25 at screening (even if taking a single PDE5).
• Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
• Agree to comply with all study related tests/procedures.

You may not qualify if:

• Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
• Previous history of priapism or penile fracture
• Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
• Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
• Psychogenic ED as determined by study investigator.
• Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
• Patients using Intra Cavernous Injection (ICI)for management of ED
• Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
• Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
• History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
• Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
• Hemoglobin a1c \>9%.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (10)

• Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1.

  PMID: 24080861 BACKGROUND

• Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5.

  PMID: 19468902 BACKGROUND

• Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493.

  PMID: 25164150 BACKGROUND

• Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13.

  PMID: 25184132 BACKGROUND

• Galliera E, Corsi MM, Banfi G. Platelet rich plasma therapy: inflammatory molecules involved in tissue healing. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):35S-42S.

  PMID: 23648197 BACKGROUND

• Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008 May 1;13:3532-48. doi: 10.2741/2947.

  PMID: 18508453 BACKGROUND

• Lin G, Shindel AW, Fandel TM, Bella AJ, Lin CS, Lue TF. Neurotrophic effects of brain-derived neurotrophic factor and vascular endothelial growth factor in major pelvic ganglia of young and aged rats. BJU Int. 2010 Jan;105(1):114-20. doi: 10.1111/j.1464-410X.2009.08647.x. Epub 2009 Jun 2.

  PMID: 19493269 BACKGROUND

• Apel PJ, Ma J, Callahan M, Northam CN, Alton TB, Sonntag WE, Li Z. Effect of locally delivered IGF-1 on nerve regeneration during aging: an experimental study in rats. Muscle Nerve. 2010 Mar;41(3):335-41. doi: 10.1002/mus.21485.

  PMID: 19802878 BACKGROUND

• Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.

  PMID: 12843410 BACKGROUND

• Kushida S, Kakudo N, Morimoto N, Hara T, Ogawa T, Mitsui T, Kusumoto K. Platelet and growth factor concentrations in activated platelet-rich plasma: a comparison of seven commercial separation systems. J Artif Organs. 2014 Jun;17(2):186-92. doi: 10.1007/s10047-014-0761-5. Epub 2014 Apr 20.

  PMID: 24748436 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Ranjith Ramasamy
• Organization: University of Miami, Miller School of Medicine - Desai Sethi Urology Institute

ramasamy@miami.edu

305-243-4562

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Male Fertility and Andrology, University of Miami

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: May 21, 2020
• Study Start: May 21, 2020
• Primary Completion: January 23, 2023
• Study Completion: April 18, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)