Changes in the Immunomodulatory Properties of Adipose Stromal Cells Due to Hemarthrosis After Knee Injury
NCT ID: NCT05687331
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-04-05
2024-04-01
Brief Summary
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* 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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with hemarthrosis
10 patients that sustained a knee trauma and have hemarthrosis during knee arthrocentesis (red color of the synovial fluid)
knee arthrocentesis
arthrocentesis of the knee joint to gather a synovial fluid sample
venipuncture
Peripheral venipuncture to gather a blood sample
MRI-scan
MRI-scan of the knee
Physical examination
Physical examination of the injured knee
KOOS questionnaire
KOOS questionnaire of the injured knee
Patients without hemarthrosis
10 patients that sustained a knee trauma and do not have hemarthrosis during knee arthrocentesis (yellow color of the synovial fluid)
knee arthrocentesis
arthrocentesis of the knee joint to gather a synovial fluid sample
venipuncture
Peripheral venipuncture to gather a blood sample
MRI-scan
MRI-scan of the knee
Physical examination
Physical examination of the injured knee
KOOS questionnaire
KOOS questionnaire of the injured knee
Interventions
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knee arthrocentesis
arthrocentesis of the knee joint to gather a synovial fluid sample
venipuncture
Peripheral venipuncture to gather a blood sample
MRI-scan
MRI-scan of the knee
Physical examination
Physical examination of the injured knee
KOOS questionnaire
KOOS questionnaire of the injured knee
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A swollen joint
* Inability to mobilise
Exclusion Criteria
* Patients using systemic immunosuppressant medication
* Patients with a contra-indication for undergoing a MRI-scan (non-compatible implants or claustrophobia for example)
* Patients with knee prosthesis
* Patients with coagulation disorders
* Patients with a history of a cruciate ligament or meniscal injury of the index knee
* Patients with a tibiofemoral fracture of the index knee due to current distortion
* In case the inclusion of the required amount of patient is reached in one the patient groups, additional patients belonging in the same patient group will not be included in the study
18 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboud umc
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Riordan EA, Little C, Hunter D. Pathogenesis of post-traumatic OA with a view to intervention. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):17-30. doi: 10.1016/j.berh.2014.02.001.
Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.
Luc B, Gribble PA, Pietrosimone BG. Osteoarthritis prevalence following anterior cruciate ligament reconstruction: a systematic review and numbers-needed-to-treat analysis. J Athl Train. 2014 Nov-Dec;49(6):806-19. doi: 10.4085/1062-6050-49.3.35.
Ayral X, Pickering EH, Woodworth TG, Mackillop N, Dougados M. Synovitis: a potential predictive factor of structural progression of medial tibiofemoral knee osteoarthritis -- results of a 1 year longitudinal arthroscopic study in 422 patients. Osteoarthritis Cartilage. 2005 May;13(5):361-7. doi: 10.1016/j.joca.2005.01.005.
Pulles AE, Mastbergen SC, Schutgens RE, Lafeber FP, van Vulpen LF. Pathophysiology of hemophilic arthropathy and potential targets for therapy. Pharmacol Res. 2017 Jan;115:192-199. doi: 10.1016/j.phrs.2016.11.032. Epub 2016 Nov 24.
Gupte C, St Mart JP. The acute swollen knee: diagnosis and management. J R Soc Med. 2013 Jul;106(7):259-68. doi: 10.1177/0141076813482831.
Wang Y, Shimmin A, Ghosh P, Marks P, Linklater J, Connell D, Hall S, Skerrett D, Itescu S, Cicuttini FM. Safety, tolerability, clinical, and joint structural outcomes of a single intra-articular injection of allogeneic mesenchymal precursor cells in patients following anterior cruciate ligament reconstruction: a controlled double-blind randomised trial. Arthritis Res Ther. 2017 Aug 2;19(1):180. doi: 10.1186/s13075-017-1391-0.
ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626.
Schelbergen RF, van Dalen S, ter Huurne M, Roth J, Vogl T, Noel D, Jorgensen C, van den Berg WB, van de Loo FA, Blom AB, van Lent PL. Treatment efficacy of adipose-derived stem cells in experimental osteoarthritis is driven by high synovial activation and reflected by S100A8/A9 serum levels. Osteoarthritis Cartilage. 2014 Aug;22(8):1158-66. doi: 10.1016/j.joca.2014.05.022. Epub 2014 Jun 10.
Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.
Other Identifiers
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NL77974.091.21
Identifier Type: -
Identifier Source: org_study_id
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