Long-term follow-up of patients from the EXCELLENT trial
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
CellProthera · NCT06521047
This study looks at the long-term health of patients from the EXCELLENT trial to see how well the treatments they received worked over 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CellProthera (industry) |
| Locations | 10 sites (Mulhouse, France and 9 other locations) |
| Trial ID | NCT06521047 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term clinical outcomes of patients who participated in the EXCELLENT clinical trial, specifically those randomized to either the Standard of Care or ProtheraCytes arm. Participants will be followed for a duration of 10 years to gather data on their health status and any relevant clinical events. The study does not involve any new interventions, focusing instead on collecting and analyzing existing patient data. By evaluating these long-term outcomes, the study seeks to provide insights into the effectiveness of the treatments administered during the EXCELLENT trial.
Who should consider this trial
Good fit: Ideal candidates are individuals who completed the last visit in the EXCELLENT trial and are within 10 years post-randomization.
Not a fit: Patients who were randomized to the ProtheraCytes group but did not receive the product from the EXCELLENT trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the long-term effectiveness and safety of treatments for acute myocardial infarction.
How similar studies have performed: Other observational studies have successfully assessed long-term outcomes in similar patient populations, indicating that this approach is both valid and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria : * Completion of the last visit in the EXCELLENT interventional clinical trial. * Participation must be within 10 years after the randomization in the EXCELLENT trial Exclusion criteria : * Patients randomized to the ProtheraCytes® group who did not receive the product of the EXCELLENT Trial are excluded. * Any other coexisting conditions that will preclude participation in the study or compromise ability to give informed consent
Where this trial is running
Mulhouse, France and 9 other locations
- GHRMSA — Mulhouse, France, France (ACTIVE_NOT_RECRUITING)
- CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel — Dijon, France (ACTIVE_NOT_RECRUITING)
- Institut Jacques Cartier — Massy, France (ACTIVE_NOT_RECRUITING)
- CHU Montpellier Arnaud-De-Villeneuve — Montpellier, France (RECRUITING)
- Hôpital Haut Levèque — Pessac, France (ACTIVE_NOT_RECRUITING)
- Hôpital de Rangueil — Toulouse, France (RECRUITING)
- Ninewells Hospital & Medical School — Dundee, United Kingdom (NOT_YET_RECRUITING)
- BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way, — Edgbaston, United Kingdom (NOT_YET_RECRUITING)
- University of Edinburgh — Edinburgh, United Kingdom (NOT_YET_RECRUITING)
- Saint Bartholomew's Hospital W Smithfield, — London, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Aude BOLLINGER, MSc
- Email: abollinger@cellprothera.com
- Phone: +33-(3)-69-71-97-71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myocardial Infarction