Prospective Validation Study of the CD8+TEMRA Cells As a Prognostic Biomarker of Healing Outcome After Fracture

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a specific type of immune cell, called CD8+ TEMRA cells, to see if they can help predict how well and quickly a broken bone will heal. Sometimes, fractures don’t heal properly, which can lead to more surgeries and longer hospital stays, creating a significant challenge for patients and healthcare systems. By identifying who may be at risk for healing problems early on, doctors can use different treatments to help improve healing outcomes.

To participate in this study, candidates must be adults aged 18 to 80 with certain types of closed fractures in the arms or legs. Participants will need to sign a consent form and have no serious infections or other health issues that could interfere with the study. If eligible, individuals can expect to have tests done to measure their CD8+ TEMRA cells. This study is currently recruiting participants, and it aims to provide valuable information that could improve care for patients with fractures in the future.

Gender

ALL

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).