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

Pharmicell

Status: Unknown

Conditions: Erectile Dysfunction

Treatments: Other: no Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03933995

PMC-P-09

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Mesenchymal stem cell

Description:

Long-term follow up of Mesenchymal stem cell group

Treatment:

Other: no Intervention