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

NCT ID: NCT03933995

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-11

Study Completion Date

2022-11-30

Brief Summary

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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

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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).

Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Mesenchymal stem cell

Long-term follow up of Mesenchymal stem cell group

no Intervention

Intervention Type OTHER

no Intervention

Interventions

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no Intervention

no Intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chungsu Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JIYEOUN JEONG, bachelor

Role: CONTACT

82-02-3496-0134

Facility Contacts

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Chungsu Kim, PhD

Role: primary

Other Identifiers

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PMC-P-09

Identifier Type: -

Identifier Source: org_study_id

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