Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmicell Co., Ltd.

Criteria

Inclusion Criteria:

Postprostatectomy Erectile Dysfunction

• A man aged 20 or older

• Who is willing to consent to participate in the study concerned with improving sexual activity after prostatectomy, the man has maintained normal sexual activity prior to prostatectomy

• Prior to prostatectomy PSA (prostate specific antigen) level<10 ng/mL

• At the time of Prostatectomy, Pathological Gleason sum ≤7

• At the time of Prostatectomy, Pathological stage ≤ T2c

• 2 years or more postprostatectomy patients with PSA level ≤ 0.04 ng/mL without additional therapy after prostatectomy

• Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I(phos-phodiesterasetype-5 inhibitors) within last 8weeks.

• IIEF, EF(erectile function) domain score is under 17

• Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.

Diabetes-associated Erectile Dysfunction

• HbA1c is between 6.5% and 10% of man over 20 years of age with diabetes

• Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I within last 8weeks.

• IIEF, EF domain score is under 17

• Who is willing to consent to participate in the study concerned with improving sexual activity

• Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.

Exclusion Criteria:

• History of bone marrow disorders

• Serum AST/ALT > 3 X upper limit of normal or Creatinine > 1.5 X upper limit of normal

• History of hypersensitivity against a gentamycin

• Severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure

• Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis test

• Positive for PSA or CEA or AFP (Carcinoembryonic antigen), history of cancer in the last five years (except Prostatic cancer) Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, diastolic pressure > 100 or < 50 mm Hg)

• HbA1c exhibit greater than 10%

• Men on anticoagulant treatment

• Have a severe infectious disease

• Testosterone level is less than 200ng/dl

• Have a penile implant or willing to it

• Patients with morphological changes of the penis

• Patient's partner is trying to conceive during the trial period

• Unwilling to participate in the study

• Participating in other clinical trials in the past 30 days

• Unable to compliance with protocol

• Inappropriate patients to participate in the study according to the investigator