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

NCT02344849 | Completed Phase 1

• 1 other identifier: Cellgram-ED
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events

  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.

  12month

Secondary Outcomes (4)

• Change From Baseline in the International Index of Erectile Function(IIEF)

  month 1, 3, 6, 9 and 12

• Penile Doppler Sonography, PDS

  month 6, 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

Study Arms (1)

Mesenchymal stem cell

EXPERIMENTAL

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

Drug: mesenchymal stem cell

Interventions

mesenchymal stem cell DRUG

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

Also known as: Cellgram-ED

Mesenchymal stem cell

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34326007 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Chungsu Kim, Ph.D

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 26, 2015
• Study Start: July 1, 2015
• Primary Completion: January 31, 2018
• Study Completion: April 1, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

KR (1)