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

An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: mesenchymal stem cell

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal stem cell; Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.	Drug: mesenchymal stem cell; Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.; Other Names: Cellgram-ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the International Index of Erectile Function(IIEF)	Description of the average variation from the screening value in each group using the Student's preordered t-test (Wilcoxon's signed bank test). Function domain; 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	month 1, 3, 6, 9 and 12
Penile Doppler Sonography, PDS	Change From Baseline in Peak systolic velocity (PSV) and End diastolic velocity (EDV), Evaluate Erection rigidity During the test. The normal maximum systolic blood flow of the cavernosal artery after injection of vasodilators is 30 cm / s or more.; PDS results are obtained 5 min, 10 min, 15 min, 20 min, 25 min and 30 min after intracavernosal injection.; The peak systolic velocity (PSV) is assessed as follows:>25 cm/s is considered to be normal, 20-25 cm/s is considered to be mild ED, 12-20 cm/s is considered to be moderate ED, <12 cm/s is considered to be severe arteriogenic impotence.; The end diastolic velocity (EDV) is assessed as follows:5 cm/s is considered to be a normal value, >5 cm/s is considered to indicate a veno-occlusive disorder.	month 6, 12
Change From Baseline in Sexual Encounter Profile (SEP) Question 2	The SEP2 survey describes cumulative success rates for 30 days, 3 months, 6 months, 9 months and 12 months after cell treatment. SEP 2 Were you able to insert your penis into your partner's vagina? Yes or No SEP 3 Did your erection last long enough to have successful intercourse? Yes or No	month 1, 3, 6, 9 and 12
Global Assessment Question (GAQ)	The GAQ survey describes cumulative success rates for 30 days, 3 months, 6 months, 9 months and 12 months after cell treatment. GAQ; Did Cellgram-ED improve your Erectile Function? Yes or No; If so, did Cellgram-ED improve the ability to have sex? Yes or No	month 1, 3, 6, 9 and 12

Collaborators and Investigators

• Sponsor: Pharmicell Co., Ltd.
• Investigators: Principal Investigator: Chungsu Kim, Ph.D, AIDS Malignancy Consortium

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 18, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: Cellgram-ED