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NCT02344849

An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.

Completed Phase 1 Last updated 7 January 2019
What this trial tests

Phase 1 trial testing mesenchymal stem cell in Erectile Dysfunction in 10 participants. Completed in 1 April 2018.

Timeline
1 July 2015
Primary endpoint
31 January 2018
1 April 2018

Quick facts

Lead sponsorPharmicell Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date1 July 2015
Primary completion31 January 2018
Estimated completion1 April 2018
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Pharmicell Co., Ltd. — full company profile →

Who can join

20 and older, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mesenchymal stromal/stem cells and their exosomes for restoration of spermatogenesis in non-obstructive azoospermia: a systemic review.
    Zhankina R, Baghban N, Askarov M, Saipiyeva D, et al · · 2021 · cited 49× · PMID 33823925 · DOI 10.1186/s13287-021-02295-9
  2. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
    Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
  3. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial.
    You D, Jang MJ, Song G, Shin HC, et al · · 2021 · cited 26× · PMID 34326007 · DOI 10.1016/j.jcyt.2021.06.001
  4. Recent advances in stem cell therapy for erectile dysfunction: a narrative review.
    Wang B, Gao W, Zheng MY, Lin G, et al · · 2023 · cited 10× · PMID 37078259 · DOI 10.1080/14712598.2023.2203811
  5. Autologous Immune Cell-Based Regenerative Therapies to Treat Vasculogenic Erectile Dysfunction: Is the Immuno-Centric Revolution Ready for the Prime Time?
    Bonanni M, Rehak L, Massaro G, Benedetto D, et al · · 2022 · cited 7× · PMID 35625828 · DOI 10.3390/biomedicines10051091
  6. Expert Consensus on Prevention and Treatment of Aging-Related Gonadal Dysfunction.
    Wang X, Ma L, Jiang S, Wen J, et al · · 2024 · cited 2× · PMID 38739936 · DOI 10.14336/ad.2024.0004
  7. Interrogating erectile dysfunction and evaluating novel therapeutic frontiers, with emphasis on stem cell strategies.
    Sonawane T, Kashte S, Khera S, Bahulkar A, et al · · 2024 · cited 1× · PMID 39023828 · DOI 10.1007/s10815-024-03165-y

Verify or expand the search:

Other trials of mesenchymal stem cell

Trials testing the same drug.

Other recruiting trials for Erectile Dysfunction

Currently open trials in the same condition.

Other Pharmicell Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02344849.

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