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

NCT03933995 | Unknown

• 1 other identifier: PMC-P-09
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Mesenchymal stem cell

Long-term follow up of Mesenchymal stem cell group

Other: no Intervention

Interventions

no Intervention OTHER

no Intervention

Mesenchymal stem cell

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).

You may qualify if:

• 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.

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Chungsu Kim, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIYEOUN JEONG, bachelor

CONTACT

82-02-3496-0134; jyjeong@pharmicell.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 1, 2019
• Study Start: March 11, 2019
• Primary Completion: February 28, 2022
• Study Completion: November 30, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

KR (1)