CompletedPhase 1

Safety of Wharton Jelly in Erectile Dysfunction

Jordan9 participantsStarted 2017-01-04

Plain-language summary

Safety of Intracavernous injection of Wharton jelly Mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

Age range25 Years – 70 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult male patients ranging from 25 to 70 years.
✓. History of chronic erectile dysfunction for at least six months.
✓. Baseline international index of erectile function (IIEF) score of \< 26.
✓. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
✓. Body Mass Index between 20-30.
✓. Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

✕. Current urinary tract or bladder infection.
✕. Clinical/Laboratory evidence of transmissible diseases.
✕. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
✕. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
✕. Current or previous malignancy.
✕. Use of any non study treatment for erectile function within 4 weeks of study treatment.
✕. Lack of willingness to continue through 6 months after study treatment.
✕. Any previous penile implant or penile vascular surgery.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: 6 months

NCT IDNCT02945449

SponsorSophia Al-Adwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-15

Who can participate

Age range25 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult male patients ranging from 25 to 70 years.
✓. History of chronic erectile dysfunction for at least six months.
✓. Baseline international index of erectile function (IIEF) score of \< 26.
✓. Not interested or able to use phosphodiesterase type 5 inhibitor (PD5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment.
✓. Body Mass Index between 20-30.
✓. Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

✕. Current urinary tract or bladder infection.
✕. Clinical/Laboratory evidence of transmissible diseases.
✕. Clinically evident penile anatomical deformities(e.g., Peyronie's disease) or history of priapism.
✕. Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
✕. Current or previous malignancy.
✕. Use of any non study treatment for erectile function within 4 weeks of study treatment.
✕. Lack of willingness to continue through 6 months after study treatment.
✕. Any previous penile implant or penile vascular surgery.