AzTrials
AzTrials

Erectile DysfunctionPhase 1NCT02344849

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

A Phase 1 study testing mesenchymal stem cell in people with Erectile Dysfunction, run by Pharmicell Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
mesenchymal stem cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Jul 2015to Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan medical center

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
mesenchymal stem cell
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mesenchymal stem cellDrug

    Also called Cellgram-ED

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

Study groups in NCT02344849
Study groupRoleWhat they receive
Mesenchymal stem cellExperimentalPatients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.
Receives: Drug: mesenchymal stem cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12month

Secondary outcomes (4)

  1. 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

    Measured: month 1, 3, 6, 9 and 12

  2. 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.

    1. PDS results are obtained 5 min, 10 min, 15 min, 20 min, 25 min and 30 min after intracavernosal injection.
    2. 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.
    3. 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.

    Measured: month 6, 12

  3. 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

    Measured: month 1, 3, 6, 9 and 12

  4. 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

    1. Did Cellgram-ED improve your Erectile Function? Yes or No
    2. If so, did Cellgram-ED improve the ability to have sex? Yes or No

    Measured: month 1, 3, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion31 Jan 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344849
Sponsor's protocol ID
Cellgram-ED
Status last verified
Jan 2019
First submitted
13 Jan 2015
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
No

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.

    PubMed 34326007

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mesenchymal stem cell in people with Erectile Dysfunction, run by Pharmicell Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and severity of adverse events (time frame: 12month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02344849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in