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NCT03418233
Randomized Clinical Trial to Evaluate the Regenerative Capacity of CardioCell in Patients With Chronic Ischaemic Heart Failure (CIHF)
Phase 2, PHASE3 trial testing CardioCell in Heart Failure in 115 participants. Completed in 31 March 2021.
27 January 2021
Quick facts
| Lead sponsor | John Paul II Hospital, Krakow |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 115 |
| Start date | 19 April 2018 |
| Primary completion | 27 January 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 5 locations across Poland |
Drugs / interventions tested
- CardioCell — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
John Paul II Hospital, Krakow
Who can join
Adults 18 to 80, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will receive the placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Human Wharton's Jelly-Cellular Specificity, Stemness Potency, Animal Models, and Current Application in Human Clinical Trials.
Stefańska K, Ożegowska K, Hutchings G, Popis M, et al · · 2020 · cited 52× · PMID 32290584 · DOI 10.3390/jcm9041102 -
Mesenchymal Stem Cell (MSCs) Therapy for Ischemic Heart Disease: A Promising Frontier.
Poomani MS, Mariappan I, Perumal R, Regurajan R, et al · · 2022 · cited 37× · PMID 35342702 · DOI 10.5334/gh.1098 -
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 -
Locoregional delivery of stem cell-based therapies.
Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564 -
Wharton's jelly mesenchymal stem cells: Future regenerative medicine for clinical applications in mitigation of radiation injury.
Sharma P, Maurya DK. · · 2024 · cited 12× · PMID 39086560 · DOI 10.4252/wjsc.v16.i7.742 -
Umbilical Cord Matrix (Wharton Jelly) Mesenchymal Stem Cells in Next-generation Myocardial Repair and Regeneration: Mechanisms and Pre-clinical Evidence.
Kwiecien E, Kot M, Czyz L, Drabik L, et al · · 2025 · cited 4× · PMID 40012283 · DOI 10.2174/011573403x372908250117092252 -
Hybrid techniques for myocardial regeneration: state of the art and future perspectives.
Kędziora A, Konstanty-Kalandyk J, Litwinowicz R, Mazur P, et al · · 2022 · cited 3× · PMID 36967853 · DOI 10.5114/aic.2022.121124 -
A comprehensive review of clinical trials and Progress in stem cell therapies for advanced heart failure.
Tran TT, Tran TL, Nguyen HT, Luong TH, et al · · 2025 · cited 1× · PMID 41079454 · DOI 10.1016/j.reth.2025.09.009
Verify or expand the search:
- PubMed search for NCT03418233
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CardioCell
Trials testing the same drug.
- NCT03423732 — Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With No-option Critical · Phase 2, PHASE3 · unknown
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other John Paul II Hospital, Krakow trials
Trials by the same sponsor.
- NCT06202638 — Hypotension Prediction Index (HPI) in Lung Resections · recruiting
- NCT06345235 — New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis · recruiting
- NCT05195658 — Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE) · recruiting
- NCT05183373 — Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease · unknown
- NCT05250349 — TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure · recruiting
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 NCT03418233 (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 John Paul II Hospital, Krakow
- Last refreshed: 9 April 2021
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/NCT03418233.
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