Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mesenchymal stem cell Long-term follow up of Mesenchymal stem cell group |
Other: no Intervention
no Intervention
|
Outcome Measures
Primary Outcome Measures
- Safety Evaluation assessed by Tumor Marker Test. [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. [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. [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
Criteria
Inclusion Criteria:
-
Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
-
Subjects who can agree to participate in the long term observation study by oneself.
Exclusion Criteria:
- Not Applicable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan medical center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Pharmicell Co., Ltd.
Investigators
- Principal Investigator: Chungsu Kim, Ph.D, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMC-P-09