Prospective Investigator Initiated Study with cell-free Autologous Conditioned Serum (ACS) to investigate potential disease modifying effects in 10 Knee Osteoarthritis Patients in MRI (MOAKS Score) over 52 weeks

Not Applicable

• Conditions: M17.0; Primary gonarthrosis, bilateral

• Registration Number: DRKS00007791
• Lead Sponsor: Privatärztliche Gemeinschaftspraxis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1) Inflammatory Knee OA (bi-lateral knee OA is allowed) with clinical evidence of knee effusion
2) >= 18 years old
3) Radiology: K-L grading: II-IV
4) NRS Pain: at least 3 out of a score of 10 in the more symptomatic knee

Exclusion Criteria

1) Any knee operations in the last 6 months or history of clinically significant trauma, surgery or diagnostic arthroscopy
2) Intra-articular injections in the last 3 months steroids, hyaluronate compounds or PRP, ACS, ACP
3) RA or autoimmune cause of arthritis
4) Active inf. predominant patella-femoral disease
5) BMI>30

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of disease-modifying effects, an intraindividual comparison based on the MOAKS score (MRI osteoarthritis knee score) between week 0 and 52 weeks.

Secondary Outcome Measures

Name	Time	Method
1) Detection of disease-modifying effects, an intraindividual comparison based on NRS (Numeric Rating Scale) between week 0 and 52 weeks.<br>2) Detection of disease-modifying effects, an intraindividual comparison based on Western Ontario and McMaster Universities Arthritis Index (WOMAC) between week 0 and 52 weeks.<br>3) Detection of disease-modifying effects, an intraindividual comparison based on SF-36 (36-Item Short Form Health Survey) between week 0 and 52 weeks.