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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.
Phase 1 trial testing mesenchymal stem cell in Erectile Dysfunction in 10 participants. Completed in 1 April 2018.
31 January 2018
Quick facts
| Lead sponsor | Pharmicell Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 July 2015 |
| Primary completion | 31 January 2018 |
| Estimated completion | 1 April 2018 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- mesenchymal stem cell
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
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.
-
Number and severity of adverse events
Time frame: 12month
Analyze the laboratory, vital sign, physical exam results from baseline to end of the study for investigate adverse reactions and view safety. An SAE suggests a significant hazard, contraindication, side-effect, or precaution. With respect to human clinical experience, this includes any event that: Results in death. Is life-threatening.\* Requires in-patient hospitalization or prolongation of ex
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):
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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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02344849
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of mesenchymal stem cell
Trials testing the same drug.
- NCT05939167 — Mesenchymal Stem Cells Treatment for AIDS Patients at Late Stage · Phase 1, PHASE2 · recruiting
- NCT03209986 — Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis · NA · unknown
Other recruiting trials for Erectile Dysfunction
Currently open trials in the same condition.
- NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT06960746 — Changing Lifestyle in OSA Males Who Suffer Metabolic Syndrome and Impotence: Is There a Response? · NA · recruiting
- NCT06872866 — The Objective of This Phase 1 Study is to Evaluate the Food Effect of 100 mg Hezkue Turbo® (ASP-001.1, Sildenafil) Under · Phase 1 · recruiting
- NCT06805513 — Actual Use Trial of Tadalafil 5 mg · Phase 3 · recruiting
Other Pharmicell Co., Ltd. trials
Trials by the same sponsor.
- NCT07431008 — Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction · recruiting
- NCT07400458 — Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration · NA · recruiting
- NCT05042206 — Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease · Phase 1 · completed
- NCT05093881 — Long-term Follow-up of Patients With Alcoholic Liver Cirrhosis Who Had Administered Cellgram-LC in PMC-P-07 Study · NA · recruiting
- NCT04615845 — Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC-PC) · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02344849 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pharmicell Co., Ltd.
- Last refreshed: 7 January 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing