An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.
Overview
- Phase
- Phase 1
- Intervention
- mesenchymal stem cell
- Conditions
- Erectile Dysfunction
- Sponsor
- Pharmicell Co., Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number and severity of adverse events
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
Detailed 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.
Investigators
Eligibility 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.
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
Arms & Interventions
Mesenchymal stem cell
Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.
Intervention: mesenchymal stem cell
Outcomes
Primary Outcomes
Number and severity of adverse events
Time Frame: 12month
Analyze the laboratory, vital sign, physical exam results from baseline to end of the study for investigate adverse reactions and view safety. An SAE suggests a significant hazard, contraindication, side-effect, or precaution. With respect to human clinical experience, this includes any event that: Results in death. Is life-threatening.\* Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Other medically important condition Life-threatening in the definition of a SAE or adverse reaction refers to an event in which the patient was at risk of death at the time of event; it does not refer to an event, which hypothetically might have caused death if it were more severe.
Secondary Outcomes
- Penile Doppler Sonography, PDS(month 6, 12)
- Change From Baseline in the International Index of Erectile Function(IIEF)(month 1, 3, 6, 9 and 12)
- Change From Baseline in Sexual Encounter Profile (SEP) Question 2(month 1, 3, 6, 9 and 12)
- Global Assessment Question (GAQ)(month 1, 3, 6, 9 and 12)