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
|Condition or disease||Intervention/treatment|
|Erectile Dysfunction||Other: no Intervention|
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|
|Estimated Enrollment :||10 participants|
|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|
Mesenchymal stem cell
Long-term follow up of Mesenchymal stem cell group
Other: no Intervention
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933995
|Contact: JIYEOUN JEONG, email@example.com|
|Korea, Republic of|
|Asan medical center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Chungsu Kim, PhD firstname.lastname@example.org|
|Principal Investigator: Chungsu Kim|
|Principal Investigator:||Chungsu Kim, Ph.D||Asan Medical Center|