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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344849
• Other study ID #: Cellgram-ED
• Status: Completed
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: January 2019
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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