CompletedPhase 1

Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD

United States5 participantsStarted 2013-08

Plain-language summary

Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based on patient reported treatment satisfaction.

Who can participate

Age range18 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.

Inclusion criteria

✓. acquired penile curvature \>15 and \<90 degrees associated with palpable penile plaque on physical examination
✓. 1 or 2 penile plaque at screening

Exclusion criteria

✕. taking the medication Coumadin
✕. unable to achieve adequate erection with penile injection to access degree of curvature
✕. undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
✕. prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorder including major depression, schizophrenia, bipolar disease
✕. history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
✕. clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
✕. received any other investigational drug within 30 days

What they're measuring

Peak Systolic Velocity without trimix (cm/s)

Timeframe: Baseline

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 6 weeks

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 3 months

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 6 months

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 12 months

Trial details

NCT IDNCT02395029

SponsorMelissa Marchand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Peyronie's Disease trials

Plain-language summary

Who can participate

Age range18 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.

Inclusion criteria

✓. acquired penile curvature \>15 and \<90 degrees associated with palpable penile plaque on physical examination
✓. 1 or 2 penile plaque at screening

Exclusion criteria

✕. taking the medication Coumadin
✕. unable to achieve adequate erection with penile injection to access degree of curvature
✕. undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
✕. prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorder including major depression, schizophrenia, bipolar disease
✕. history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
✕. clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
✕. received any other investigational drug within 30 days

What they're measuring

Peak Systolic Velocity without trimix (cm/s)

Timeframe: Baseline

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 6 weeks

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 3 months

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 6 months

Peak Systolic Velocity without trimix (cm/s)

Timeframe: 12 months