Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Injected Intracavernously

NCT04594850 | Completed Phase 2

• 1 other identifier: PMC-P-10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value

  Descriptive statistics for the amount of change at administration of the investigational drug compared to the baseline value for each administration group are presented and analyzed by an analysis of covariance (ANCOVA) Erectile Function (Q1,2,3,4,5,15) : Min 6 \~ Max 30 Orgasmic Function (Q9,10) : Min 2 \~ Max 10 Sexual Desire (Q11,12) : : Min 2 \~ Max 10 Intercourse Satisfaction (Q6,7,8): : Min 3 \~ Max 15 Overall Satisfaction (Q13,14) : Min 2 \~ Max 10

  6 month

Secondary Outcomes (4)

• The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value

  month 1, 3, 6, 9 and 12

• Changes in SEP Q 2 and Q 3 evaluation after administration of investigational drug compared to baseline

  month 1, 3, 6, 9 and 12

• Global Assessment Question (GAQ) evaluation after administration of investigational drugs

  month 1, 3, 6, 9 and 12

• Changes in Penile Doppler Sonography(PDS) level after administration of clinical trial drug compared to baseline

  month 6, 12

Study Arms (2)

Placebo-Control group

NO INTERVENTION

Single intracavernous injection of Placebo Oral PDE5-inhibitor can take daily and on demand.

Injection group: Cellgram-ED

EXPERIMENTAL

Single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take daily and on demand.

Biological: Cellgram-ED

Interventions

Cellgram-ED BIOLOGICAL

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

Also known as: Autologous bone marrow derived mesenchymal stem cell

Injection group: Cellgram-ED

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged 19 to 80 years old at screening
• Patients who maintained normal foot function before prostatectomy and are interested in restoring sexual function after surgery
• PSA level \<10 ng/mL before prostatectomy
• Pathological Gleason sum ≤ 7(3+4 or 4+3) factor during prostatectomy
• Local lesions that did not metastasize during prostatectomy (pT2, N0, M0 stage) factors
• Patients more than 1 year after prostatectomy and PSA ≤ 0.04 ng/mL when screened without additional treatment other than surgery
• 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.
• Total score of 10 or more and 17 or less in the EF (Erectile function) field\* of the International Erectile Function Questionnaire
• \* 1, 2, 3, 4, 5, 15 questions for EF erectile function in the international erectile function questionnaire
• Prevalence for erectile dysfunction at screening with more than 6 months
• Who are willing to engage in sexual activity more than 4 times a month and have a constant partner for at least 3 months
• Who do not have difficulty reading and understanding the contents of the questionnaire and who fill out a complete questionnaire
• A person who voluntarily agrees to participate in this clinical trial and has signed the consent form by the subject and the subject partner

You may not qualify if:

• Severe cardiovascular disease (angina pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
• Who cannot collect bone marrow due to bone marrow disease, etc.
• Those with the following medical history/companion diseases A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive impairment, dementia or psychiatric disorder D. Alcohol or substance abuse E. Priapism F. Severe respiratory diseases (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) G. Stroke H. Systemic autoimmune disease
• Those with the following test results at the screening visit A. Liver disease or abnormal liver function (AST or ALT ≥ 3 times the normal upper limit of the organ) B. Severe renal impairment (serum creatinine≥ 2 mg/dL) C. Positive factors for pathogenic microbial tests (Hbs Ag, HCV Ab, HIV Ab, Syphilis) D. Uncontrolled high blood pressure (systolic blood pressure \>170 mmHg or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg, diastolic blood pressure \<50 mmHg) E. Who are outside the normal range of tumor marker tests (PSA, CEA, AFP) F. Hemorrhagic tendency (PT and aPTT\> ULN x 1.5) G. Untreated hypogonadism or serum testosterone hormone less than 200 ng/dL
• Those who possess the following therapeutic powers at screening A. Who are being treated for severe systemic or local infection B. Long-term use of anticoagulant (warfarin) (administered for more than 3 months as anticoagulant therapy) C. Vacuum compressor or intracavernous injection therapy within 7 days before screening (prostaglandin E1, papaverine, phentolamine, etc.) D. Immunosuppressants, alpha blockers or male hormones (androgens, anti-androgens) within 28 days prior to screening
• Penile anatomical malformations (ex: Peyronie's disease) or penile implants or penile vascular procedures
• Who are receiving drugs\* that are expected to affect the results of this clinical trial when judged by the investigator
• If the partner is a woman of childbearing potential, those who are not willing to use an appropriate contraceptive method\*\* during the clinical trial period
• \*\*Contraceptive administration and implantation or intrauterine device, infertility procedures (vapectomy, tubal ligation, etc.), blocking method (condom, contraceptive diaphragm, vaginal sponge or cervical cap)
• Who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received clinical investigational drugs/investigational medical devices or received procedures
• Who have or will be administered other cell therapy products
• A person who is judged to be inappropriate to participate in this test when judged by the examiner
• Total score of 10 or more and 17 or less in the EF (Erectile function) field\* of the International Erectile Function Questionnaire (IIEF)
• \* 1, 2, 3, 4, 5, 15 questions for EF erectile function in the international erectile function questionnaire
• Who attempts sexual activity more than 4 times during the run-in period and has a failure rate (Sexual Encounter Profile) of 50% or more

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (4)

Asan medical center

Seoul, South Korea

Location

Ewha womans university medical center

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Seoul ST. Mary's hospital

Seoul, South Korea

Location

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 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: October 19, 2020
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

KR (4)