Validation of CD8+TEMRA Cells as a Prognostic Biomarker for Fracture Healing
Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
This study is testing if measuring certain immune cells in the blood can help predict which patients with fractures might have trouble healing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 7 sites (Münster, North Rhine-Westphalia and 6 other locations) |
| Trial ID | NCT06658379 on ClinicalTrials.gov |
What this trial studies
This study aims to validate CD8+ TEMRA cells as a prognostic biomarker for patients at risk of impaired fracture healing. By assessing the immunological profile of patients with closed fractures, the study seeks to identify those who may experience delayed healing or non-union. Blood samples will be taken preoperatively to measure CD8+ TEMRA cell levels, and the healing process will be monitored through imaging and clinical evaluations over a specified period. The goal is to improve patient outcomes by enabling individualized therapeutic strategies based on these biomarkers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with closed fractures of the humerus, forearm, femur, or tibia.
Not a fit: Patients with cancer-related fractures, periprosthetic fractures, or severe uncontrolled diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification of patients at risk for poor fracture healing, allowing for timely and targeted interventions.
How similar studies have performed: Other studies have explored prognostic biomarkers in fracture healing, but the specific validation of CD8+ TEMRA cells is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female subjects * subjects \> 18 to 80 years of age at the time of screening * closed fractures * fractures of the humerus-shaft, forearm-shaft, femur and tibia * Subjects suffering monotrauma or comparable with monotrauma, due to comparable post-surgery mobilisation * osteosynthesis * subject has signed an informed consent form * legal capacity Exclusion Criteria: * cancer related fractures * periprosthetic fractures * known active Hepatitis B virus or Hepatitis C virus infection at screening * known human immunodeficiency virus (HIV) infection, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease * active malignancy or history of malignancy within 5 years prior to screening * known diagnosis of moderate to severe dementia based on subject's medical history or severe psychiatric disorder * known history of drug or alcohol abuse in the past 12 months, based on self-report or medical record * history of autologous/allogeneic bone marrow (BM) or solid organ transplantation * exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening * pregnancy * subject is currently enrolled in an investigational device or drug trial, or has not yet completed a period of at least 30 days since ending other investigational device or drug trial(s). * subject is detained or institutionalized under a court order or administrative order * in the opinion of the investigator, the subject is unsuitable for participating in the study (patient compliance).
Where this trial is running
Münster, North Rhine-Westphalia and 6 other locations
- Clinic for Trauma, Hand and Reconstructive Surgery University Hospital Münster (UKM) — Münster, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital University Centre for Orthopaedics and Trauma Surgery Dresden — Dresden, Saxony, Germany (Recruiting)
- University Hospital Clinic and Polyclinic for Orthopaedics, Trauma Surgery and Plastic Surgery Leipzig — Leipzig, Saxony, Germany (Recruiting)
- Unfallkrankenhaus Berlin — Berlin, State of Berlin, Germany (Recruiting)
- Charité Universitätsmedizin Berlin, Centre for Musculoskeletal Surgery (CMSC) — Berlin, State of Berlin, Germany (Recruiting)
- Vivantes Klinikum Spandau Berlin — Berlin, State of Berlin, Germany (Recruiting)
- Clinic for Orthopaedics and Trauma Surgery Jena/Eisenberg — Eisenberg, Thuringia, Germany (Recruiting)
Study contacts
- Principal investigator: Simon Reinke, Phd — Charité Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT)
- Study coordinator: Simon Reinke, Phd
- Email: simon.reinke@bih-charite.de
- Phone: +49 (0)30-450-659617
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.