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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933995
• Other study ID #: PMC-P-09
• Status: Recruiting
• Start date: March 11, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2020
• Source: Pharmicell Co., Ltd.
• Contact: JIYEOUN JEONG, bachelor
• Phone: 82-02-3496-0134
• Email: jyjeong[@]pharmicell.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• no Intervention
no Intervention

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation assessed by Tumor Marker Test.	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.	5 year(+-30 days)
Primary	Safety Evaluation assessed by Serious Adverse Events, cancer incidence and recurrence of prostate cancer.	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.	5 year(+-30 days)
Primary	Safety Evaluation assessed by Vital Signs.	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.	5 year(+-30 days)