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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

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

Clinicaltrials.gov identifier NCT03933995

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

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:Erectile Dysfunction
  • Intervention/Treatment: Other: no Intervention
  • Phase: N/A
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
  • 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 2019
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: November 2022
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Mesenchymal stem cell
Long-term follow up of Mesenchymal stem cell group
Other: no Intervention
no Intervention
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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

Locations

Korea, Republic of
Asan medical center
Seoul

Sponsors and Collaborators

Pharmicell Co., Ltd.

Investigators

Principal Investigator: Chungsu Kim, Ph.D Asan Medical Center

More Information
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Erectile Dysfunction