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NCT Number: NCT07431008

Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction

This phase II clinical trial with safety follow-up is designed to evaluate the efficacy and safety of Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) administered via intracavernous injection in patients with erectile dysfunction after radical prostatectomy.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Asan medical center, Seoul, South Korea

Loading trial locations.

About this study

Safety evaluations will be conducted over a period of 4 years (±30 days) from the completion date of the parent clinical trial. During the safety follow-up period, participants will be monitored for adverse events, serious adverse events, and other clinically relevant safety parameters to assess the long-term safety profile of Cellgram-ED.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who previously participated in the parent clinical trial and received the cell therapy (Cellgram-ED).
  • Participants who have provided written informed consent to participate in this safety follow-up study.

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. Tumor Marker Levels

    Time frame: Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.

    Long-term safety will be evaluated by assessing changes in tumor marker levels including prostate-specific antigen (PSA), alpha-fetoprotein (AFP), and carcinoembryonic antigen (CEA) during the safety follow-up period.

  2. Serious Adverse Events

    Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.

    The number of participants experiencing serious adverse events during the safety follow-up period.

  3. New Cancer Development

    Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.

    The number of participants with newly diagnosed malignancies during the safety follow-up period.

  4. Prostate Cancer Recurrence

    Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.

    The number of participants with recurrence of prostate cancer during the safety follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

daeun jung

CONTACT

[email protected]

82-2-3496-0134

Sponsors and collaborators

Lead sponsor

Pharmicell Co., Ltd.

Industry

Registry information

Official study title

A Safety Follow-up Study of a Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Cellgram-ED (Autologous Bone Marrow-Derived Mesenchymal Stem Cells) in Patients With Post-Radical Prostatectomy Erectile Dysfunction

Acronym: Cellgram-ED

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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