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: October 22, 2020
• Sponsor: Pharmicell Co., Ltd.
• 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
• 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

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

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