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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mesenchymal stem cell
Sponsored by
Pharmicell Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asan medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stem cell

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
January 13, 2015
Last Updated
January 7, 2019
Sponsor
Pharmicell Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02344849
Brief Title
Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction
Official Title
An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell
Arm Type
Experimental
Arm Description
Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.
Intervention Type
Drug
Intervention Name(s)
mesenchymal stem cell
Other Intervention Name(s)
Cellgram-ED
Intervention Description
Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.
Primary Outcome Measure Information:
Title
Number and severity of adverse events
Description
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.
Time Frame
12month
Secondary Outcome Measure Information:
Title
Change From Baseline in the International Index of Erectile Function(IIEF)
Description
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
Time Frame
month 1, 3, 6, 9 and 12
Title
Penile Doppler Sonography, PDS
Description
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.
Time Frame
month 6, 12
Title
Change From Baseline in Sexual Encounter Profile (SEP) Question 2
Description
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
Time Frame
month 1, 3, 6, 9 and 12
Title
Global Assessment Question (GAQ)
Description
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
Time Frame
month 1, 3, 6, 9 and 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chungsu Kim, Ph.D
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34326007
Citation
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.
Results Reference
derived

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

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