Madrid / Düsseldorf (ots) - Observational Study published in "PLoS ONE" by Spanish Researchers
Osteoarthritis (OA) of the knee is a very common and
until now an incurable disease affecting 10-15 percent of adults aged over 60 years worldwide
(WHO, 2013). It causes huge socio-economic costs due to pain, loss of function and stiffness of
the joint. There are surgical treatment options, like joint replacement, and non-surgical treatment
options, such as intra-articular injections, which can improve symptoms of OA. Medicines like
hyaluronic acid (HA), corticosteroids, platelet-rich plasma or autologous conditioned serum (ACS/
Orthokine®) can be injected directly into the joint. ACS is an autologous blood product derived from
the patien's own blood.
To further investigate clinical efficacy of ACS the Spanish team of Dr. Jaime Baselga García-
Escudero and Dr. Pedro Miguel Hernández Trillos set up a prospective observational study on
unilateral knee osteoarthritis which has been published recently in the journal "PLoS ONE",
entitled: "Treatment of Osteoarthritis of the Knee with a Combination of Autologous Conditioned
Serum and Physiotherapy: A Two-Year Observational Study".
In this trial 118 patients participated over 24 months. The researchers applied strict inclusion
criteria and excluded for example patients who had prior medication. Participants of the trial were
classified according Kellgren-Lawrence grades I-IV. State-of-the-art measurements such as the
Numeric Rating Scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis
Index (WOMAC) global score were used.
The mean age of the participants was 59.1, ranging from 34-81 years - both men and woman. 80
of 118 patients showed OA Kellgren-Lawrence grade III. The average pain at the beginning of the
trial was 8.1 of 10 maximum (NRS) which correlated with high WOMAC pain score (17.9 out of 20).
The outcome of WOMAC global and WOMAC function were increased, too.
One patient discontinued the treatment and decided for joint replacement - however his data have
been included in the analysis. Patients received four intra-articular injections of 2 mL of ACS once
weekly over four weeks. The injection therapy was followed by 30 sessions of physiotherapy four
weeks after the last injection.
In this observational study of ACS combined with physiotherapy pain scores declined significantly
by over 60 percent during the first three months after treatment and remained more or less
unchanged over the time frame. This effect on pain correlated with the WOMAC pain score: over
24 months the pain score was reduced by 86 percent from 17.9 to 2.5 with a highly significant p-value
of p<0.001. The WOMAC global score and WOMAC function scores decreased, too. The only
parameter that showed poor change was stiffness, which decreased from 3.36 to 3.3 without
statistical significance. The results from this study were independent from age, gender, weight and
stage of disease. "The improvement in pain and function reported in this observational study is
very impressive", said Prof. Dr. Peter Wehling, CEO of Orthogen AG, Düsseldorf, Germany.
A limitation of the study by Baselga García-Escudero and Miguel Hernández Trillos is the lack of a
control group and of blinding, as this study was planned and performed as a prospective
observational study. Thus evidence is given by the Spanish team of the efficacy of ACS combined
with physiotherapy in the treatment of knee OA under daily routine conditions.
Orthokine®, branded in Germany Orthokin®, is an autologous blood product derived from the
patient's own blood. For ACS treatment blood is collected from the patient using EOTII syringes
(Orthogen Lab Services GmbH, Düsseldorf, Germany) and incubated at 37°C for six hours.
Subsequently, the blood is centrifuged at 3000 g for ten minutes. The supernatant conditioned
serum is collected, filtered through a syringe tip filter and either injected intra-articularly or frozen at
-20°C until clinical use.
Baselga García-Escudero J, Miguel Hernández Trillos P (2015) Treatment of Osteoarthritis of the
Knee with a Combination of Autologous Conditioned Serum and Physiotherapy: A Two-Year
Observational Study. PLoS ONE 10(12): e0145551. doi: 10.1371/journal.pone. 0145551
PLoS one is an inclusive, peer-reviewed, open-access resource from the Public Library of Science
with an impact factor of currently 3,23. http://journals.plos.org/plosmedicine/s/journal-information
Original-Content von: Orthogen AG, übermittelt durch news aktuell
Peter Wehling MD, PhD
Phone + 49 211 38700 12
Fax + 49 211 38700 10