Erectile DysfunctionNCT03933995
Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Pharmicell Co., Ltd. at 1 site in South Korea.
Trial summary
This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2019to 30 Nov 2022
- Phase
- Observational
- 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
Study population: Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
Who may be able to join
- Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
- Subjects who can agree to participate in the long term observation study by oneself.
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan medical center
Seoul
Chungsu Kim, PhD, cskim@amc.seoul.kr
Chungsu Kim
About this study
Official title: Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction
This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).
Read the detailed description
This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).
This trial is planned to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in patients with erectile dysfunction subject. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, Serious Adverse Events, cancer incidence, recurrence of prostate cancer and vital sign).
- Conditions
- Erectile Dysfunction
- Being tested
- no Intervention
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no InterventionOther
no Intervention
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell | Long-term follow up of Mesenchymal stem cell group Receives: Other: no Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation assessed by Tumor Marker Test.
Tumor Marker Test(reported in ng/mL): PSA, AFP, CEA Tumor Marker Test is optional item, not mandatory.
In this study, tumor markers divided into which are classified as "Normal / Not clinical significant / Clinical significant" abnormalities and analysis the frequency and proportion.
Measured: 5 year(+-30 days)
Safety Evaluation assessed by Serious Adverse Events, cancer incidence and recurrence of prostate cancer.
Safety Evaluation assessed by Tumor Marker Test, patient reporting and vital signs
For each subject who has had one or more serious adverse events since the ongoing clinical trial, the severity of the adverse reaction should be provided for each causal relationship, and the incidence of serious adverse events should be analyzed.
Measured: 5 year(+-30 days)
Safety Evaluation assessed by Vital Signs.
Vital Sign : Blood pressure(reported in mmHg), Pulse(reported in time/min) Vital Sign is optional item, not mandatory.
The vital sign values obtained from this study were compared for each group. Baseline statistics (mean, standard deviation, median, maximum, and minimum) are presented, and clinically significant figures are summarized and presented based on the normal range for each value.
Measured: 5 year(+-30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start11 Mar 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chungsu Kim, Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933995
- Sponsor's protocol ID
- PMC-P-09
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03933995
- Acronym / sponsor ID
- PMC-P-09
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).
Detailed description
This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).
This trial is planned to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in patients with erectile dysfunction subject. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, Serious Adverse Events, cancer incidence, recurrence of prostate cancer and vital sign).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell | – | Other: no InterventionLong-term follow up of Mesenchymal stem cell group |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
Key inclusion criteria (2 listed)
- Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
- Subjects who can agree to participate in the long term observation study by oneself.
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no Interventionno Intervention | Other | Mesenchymal stem cell |
Primary outcome
Safety Evaluation assessed by Tumor Marker Test.
Time frame: 5 year(+-30 days)
Tumor Marker Test(reported in ng/mL): PSA, AFP, CEA Tumor Marker Test is optional item, not mandatory. In this study, tumor markers divided into which are classified as "Normal / Not clinical significant / Clinical significant" abnormalities and analysis the frequency and proportion.
Safety Evaluation assessed by Serious Adverse Events, cancer incidence and recurrence of prostate cancer.
Time frame: 5 year(+-30 days)
Safety Evaluation assessed by Tumor Marker Test, patient reporting and vital signs For each subject who has had one or more serious adverse events since the ongoing clinical trial, the severity of the adverse reaction should be provided for each causal relationship, and the incidence of serious adverse events should be analyzed.
Safety Evaluation assessed by Vital Signs.
Time frame: 5 year(+-30 days)
Vital Sign : Blood pressure(reported in mmHg), Pulse(reported in time/min) Vital Sign is optional item, not mandatory. The vital sign values obtained from this study were compared for each group. Baseline statistics (mean, standard deviation, median, maximum, and minimum) are presented, and clinically significant figures are summarized and presented based on the normal range for each value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chungsu Kim, Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIYEOUN JEONG, bachelor (82-02-3496-0134, jyjeong@pharmicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation assessed by Tumor Marker Test. (time frame: 5 year(+-30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.