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

Pharmicell

Status and phase

Completed

Phase 1

Conditions

Erectile Dysfunction

Treatments

Drug: mesenchymal stem cell

Study type

Interventional

Funder types

Industry

Identifiers

NCT02344849

Cellgram-ED

Details and patient eligibility

About

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

Full description

Cellgram-ED is autologous bone marrow-derived mesenchymal stem cells ex vivo expanded for approximately 30 days. Ten patients (Diabetes -associated ED; 5 patients, Postprostatectomy; 5patients) will be injected Cellgram-ED directly into the intracavernous. Patient will be evaluated the safety and potential efficacy of MSC.

Enrollment

10 patients

Sex

Male

Ages

20+ years old

Volunteers

No Healthy Volunteers

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