Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to

Status Recruiting

Clinical Trial Summary

The goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. The main question[s] it aims to answer are: - What is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma? - What are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy? Participants will: - undergo blood withdrawal - undergo knee arthrocentesis for synovial fluid sample collection - physical examination - fill out a questionnaire on knee complaints

Clinical Trial Description

Recent studies have found an amelioration of post-traumatic osteoarthritis by the use of adipose-derived stromal cells (ASC's) in an experimental animal model. This amelioration was only seen under inflammatory conditions. The presence of hemarthrosis has not been taken into account in the before mentioned animal model, and might have cytotoxic effects on ASC's and aggravate the inflammatory response. The objective of this study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis and its effects on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy. Therefore the investigators designed a pilot study with exploratory analyses in and with synovial fluid in a longitudinal cohort. Our study population will consist of 20 patients, older than 18 years, who sustained a recent knee trauma and are presented to the emergency department.The investigators will gather synovial fluid and blood samples for laboratory analysis perform and physical examination and provide questionnaires for clinical follow-up. The main study endpoint are the anti-inflammatory capacities of ASC's in synovial fluid that contains blood as a result of hemarthrosis after knee injury. ;

Study Design

Related Conditions & MeSH terms

Hemarthrosis
Knee Injuries
Osteoarthritis, Knee
Post-Traumatic Osteoarthritis of Knee
Wounds and Injuries

Clinical Trial Details

NCT number	NCT05687331
Study type	Observational
Source	Radboud University Medical Center
Contact	Bob Evers, Drs/Msc
Phone	06-29630837
Email	Bob.J.Evers@radboudumc.nl
Status	Recruiting
Phase
Start date	April 5, 2022
Completion date	April 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury — CASH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms