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

NCT ID: NCT02344849

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-04-30

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal stem cell

Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.

Group Type: EXPERIMENTAL

mesenchymal stem cell

Intervention Type: DRUG

Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.

Interventions

mesenchymal stem cell

Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.

Intervention Type: DRUG

Other Intervention Names

Cellgram-ED

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.

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chungsu Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

References

You D, Jang MJ, Song G, Shin HC, Suh N, Kim YM, Ahn TY, Kim CS. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial. Cytotherapy. 2021 Oct;23(10):931-938. doi: 10.1016/j.jcyt.2021.06.001. Epub 2021 Jul 27.

Reference Type: DERIVED

PMID: 34326007 (View on PubMed)

Other Identifiers

Cellgram-ED

Identifier Type: -

Identifier Source: org_study_id