NCT06658379 Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture
| NCT ID | NCT06658379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Fracture Non Union |
| Study Type | OBSERVATIONAL |
| Enrollment | 640 participants |
| Start Date | 2016-12 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 640 participants in total. It began in 2016-12 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In approx. 10-15% of all fracture patients, there is a prolonged healing time or even a complete absence of fracture healing (non-union). As a result, these patients require further surgical interventions, combined with renewed or prolonged hospitalisation/rehabilitation and incapacity to work. To summarise, this therefore represents a serious socio-economic problem. At present, there is no prognostic method for the early prediction of patients at risk of a disturbed healing process. However, if these patients are successfully stratified, there are already a variety of therapeutic strategies available to additionally stimulate fracture healing. Therefore, the aim is to conduct a prospective clinical study to validate CD8+ TEMRA cells as a prognostic marker of impaired fracture healing. The investigators assume that preoperative CD8+ TEMRA cell expression represents a prognostic biomarker with high diagnostic precision for differentiating between a) normal healing patients, b) delayed healing patients and c) pseudarthrosis patients. Furthermore, the sensitivity and specificity should be high enough, health-economically significant and realisable in clinical routine.
Eligibility 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).
Contact & Investigator
Simon Reinke, Phd
PRINCIPAL INVESTIGATOR
Charité Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT)
Frequently Asked Questions
Who can join the NCT06658379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fracture Non Union. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06658379 currently recruiting?
Yes, NCT06658379 is actively recruiting participants. Contact the research team at simon.reinke@bih-charite.de for enrollment information.
Where is the NCT06658379 trial being conducted?
This trial is being conducted at Münster, Germany, Dresden, Germany, Leipzig, Germany, Berlin, Germany and 3 additional locations.
Who is sponsoring the NCT06658379 clinical trial?
NCT06658379 is sponsored by Charite University, Berlin, Germany. The principal investigator is Simon Reinke, Phd at Charité Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT). The trial plans to enroll 640 participants.