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

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 - MOAKS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007791

Enrollment

Registered

2016-04-21

Start date

2018-05-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M17.0

Interventions

Group 1: With the medical device EOT®II, using a special process the investigator prepares cell-free autologous conditioned serum which will be injected intra-articular in knee joint six times within

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
1) Detection of disease-modifying effects, an intraindividual comparison based on NRS (Numeric Rating Scale) between week 0 and 52 weeks. 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. 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.	—

Measure

Time frame

1) Detection of disease-modifying effects, an intraindividual comparison based on NRS (Numeric Rating Scale) between week 0 and 52 weeks. 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. 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.

—

Countries

Germany

Contacts

Public ContactJens Hartmann

Privatärztliche Gemeinschaftspraxis

praxis@wehling-hartmann.de+49(0)211-60 255-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026