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Trial record 8 of 62 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03933995
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment
Erectile Dysfunction Other: no Intervention

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).


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mesenchymal stem cell
Long-term follow up of Mesenchymal stem cell group
Other: no Intervention
no Intervention




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
Criteria

Inclusion Criteria:

  1. Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
  2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion Criteria:

  • Not Applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933995


Contacts
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Contact: JIYEOUN JEONG, bachelor 82-02-3496-0134 jyjeong@pharmicell.com

Locations
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Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: Chungsu Kim, PhD       cskim@amc.seoul.kr   
Principal Investigator: Chungsu Kim         
Sponsors and Collaborators
Pharmicell Co., Ltd.
Investigators
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Principal Investigator: Chungsu Kim, Ph.D Asan Medical Center

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Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT03933995     History of Changes
Other Study ID Numbers: PMC-P-09
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders