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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 : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Tracking Information
First Submitted Date April 15, 2019
First Posted Date May 1, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date March 11, 2019
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction
Official Title Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction
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).
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
Condition Erectile Dysfunction
Intervention Other: no Intervention
no Intervention
Study Groups/Cohorts Mesenchymal stem cell
Long-term follow up of Mesenchymal stem cell group
Intervention: Other: no Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 28, 2019)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: JIYEOUN JEONG, bachelor 82-02-3496-0134 jyjeong@pharmicell.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03933995
Other Study ID Numbers PMC-P-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Pharmicell Co., Ltd.
Study Sponsor Pharmicell Co., Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Chungsu Kim, Ph.D Asan Medical Center
PRS Account Pharmicell Co., Ltd.
Verification Date October 2020