Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
NCT ID: NCT04396795
Last Updated: 2024-01-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2020-05-21
2023-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRP group
Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days
Autologous Platelet Rich Plasma
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.
Placebo group
Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Saline solution
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
Interventions
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Autologous Platelet Rich Plasma
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.
Saline solution
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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%.
30 Years
75 Years
MALE
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Ranjith Ramasamy, MD
Director of Male Fertility and Andrology, University of Miami
Principal Investigators
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Ranjith Ramasamy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Miller School of Medicine
Miami, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20200373
Identifier Type: -
Identifier Source: org_study_id
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