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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396795
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

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)

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Autologous Platelet Rich Plasma Other: Saline solution Phase 2

Detailed Description:

Platelet-derived therapies are a growing trend across multiple medical and surgical specialties, mainly orthopedics for conditions such as bone and soft tissue trauma, inflammatory conditions, and chronic pain syndromes. One of the most well described platelet-based therapies is autologous platelet-rich plasma (PRP). This concentrate is then administered via injection. When platelets are activated, they release these growth differentiation factors, facilitating even nerve repair and regeneration. Growth factors act locally and are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation and angiogenesis.The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing, as well as tissue regeneration.

Although most of the studies focusing on PRP injections have been relatively small and heterogenous, they largely support the concept of administration in terms of safety, while efficacy remains uncertain.

When platelets are activated, they release many kinds of growth differentiation factors and a few types have been found to facilitate nerve repair and regeneration. Moreover, corporeal dysfunction in ED due to smooth muscle atrophy or other intra-cavernosal pathology can lead to corporo-venous occlusive erectile dysfunction despite a normal arterial inflow. Rejuvenating the Corporeal tissues with PRP, which is well known for its growth and healing factors, is a possible modality as a potential treatment for erectile dysfunction according to Alkhayal et al. In their retrospective study examining the efficacy of one intra-cavernosal PRP injection to 40 ED patients, they reported that mean IIEF-5 score before treatment was 13 (5-20) and post treatment IIEF-5 = 17 (7-24), (p < 0.001).

To date, there are no treatments that address the underlying cause of endothelial dysfunction, although LIST treatment for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control, Double-Blind, Placebo Controlled, Multicenter Clinical Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma Injection Treatment for Erectile Dysfunction.
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP group
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
Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
Other Name: PRP

Placebo Comparator: Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Other: Saline solution
Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum




Primary Outcome Measures :
  1. Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 9 weeks ]
    Treatment efficacy of PRP will be assessed via the percentage of participants achieving mild clinically important difference (MCID) in their IIEF-EF scores from baseline to 4 weeks after final treatment. International Index of Erectile Function - Erectile Function Subdomain Score (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. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.


Secondary Outcome Measures :
  1. Percentage of participants achieving MCID in IIEF-EF [ Time Frame: 24 weeks ]
    Treatment efficacy of PRP will be assessed via the percentage of participants achieving MCID in their IIEF-EF scores from baseline to 2 and 24 weeks after final treatment. 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. MCID is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.

  2. Change in IIEF-EF Scores [ Time Frame: Baseline up to Week 9, Baseline up to Week 17, Baseline up to Week 29 ]
    IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function.

  3. Change in doppler ultrasound parameters [ Time Frame: Baseline, Up to 29 weeks ]
    Change in Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) assessed in cm/sec via ultrasound.

  4. Incidence of adverse events [ Time Frame: 24 weeks ]
    Safety will be evaluated via the incidence of adverse events as assessed by treating physician



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be Male
  2. Be 30 to 75 years of age (inclusive).
  3. Be able to provide written informed consent.
  4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
  5. Sexually active in a stable, heterosexual relationship of more than three months duration.
  6. IIEF-EF score 11-25 at screening (even if taking a single PDE5).
  7. 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.
  8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

  1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
  2. Previous history of priapism or penile fracture
  3. 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%).
  4. 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.
  5. Psychogenic ED as determined by study investigator.
  6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
  7. Patients using Intra Cavernous Injection (ICI)for management of ED
  8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
  9. 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.
  10. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
  11. 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.
  12. Hemoglobin a1c >9%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396795


Contacts
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Contact: Thomas Masterson, MD 305-243-4562 tmasterson@med.miami.edu
Contact: Ranjith Ramasamy, MD 305-243-4562 ramasamy@miami.edu

Locations
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United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Ranjith Ramasamy, MD    305-243-4562    ramasamy@miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
Publications:

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Responsible Party: Ranjith Ramasamy, MD, Director of Male Fertility and Andrology, University of Miami, University of Miami
ClinicalTrials.gov Identifier: NCT04396795    
Other Study ID Numbers: 20200373
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ranjith Ramasamy, MD, University of Miami:
ED
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders