Trial document




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  DRKS00007791

Trial Description

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Title

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

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Trial Acronym

MOAKS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The influence of a cell-free autologous conditioned serum (ACS) will be investigated on the processes of osteoarthritis of the knee. Autolog conditioned serum is a special serum which is obtained from the own blood of the respective patient. This serum contains a significantly higher concentration of anti-inflammatory substances and various growth factors, as conventional, obtained from whole blood serum.

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Brief Summary in Scientific Language

In this explorative study the potential disease modifying effect of cell-free autologous conditioned serum (ACS) will be investigated via centrilized MOAKS Score evaluation in 10 patients with magnetic resonance imaging (MRI)-proven knee osteoarthritis (OA) (Kellgren-Lawrence Grades II–IV). Efficacy and safety of cell-free ACS will be investigated over 52 weeks.

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Organizational Data

  •   DRKS00007791
  •   2016/04/21
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  •   yes
  •   Approved
  •   016/1210, Freiburger Ethik-Kommission International
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Secondary IDs

  •   U1111-1167-0267 
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Health Condition or Problem studied

  •   M17.0 -  Primary gonarthrosis, bilateral
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Interventions/Observational Groups

  •   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 two weeks.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2018/05/02
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Privatärztliche Gemeinschaftspraxis
    • 40219  Düsseldorf
    • Germany
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    • Privatärztliche Gemeinschaftspraxis
    • Mr.  Dr. med.  Jens  Hartmann 
    • Stadttor 1
    • 40219  Düsseldorf
    • Germany
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    • Privatärztliche Gemeinschaftspraxis
    • Mr.  Dr.med.  Jens  Hartmann 
    • Stadttor 1
    • 40219  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Orthogen AG
    • 40212  Düsseldorf
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.