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Autologous conditioned serum is more effective than HA, saline for OA treatment
Researchers report seeing significant differences between treatment groups at 2-year follow-up.
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Intra-articular injections of an autologous conditioned serum relieved pain and improved quality of life in osteoarthritis patients better than hyaluronan or saline injections in a recent trial.
Researchers in Düsseldorf, Germany, found that injecting patients with their own blood after conditioning it — thus elevating the blood level of endogenous anti-inflammatory cytokines — relieved pain and inflammation, and is beneficial in the treatment of knee osteoarthritis (OA).
They presented results with the procedure and serum [Orthokine; Orthogen] at the 8th European Federation of National Associations of Orthopaedics and Traumatology Congress.
In the procedure, the blood is withdrawn from the patient using a specialized Orthokine syringe. The white blood cells contained in the blood immediately begin to produce IL-1Ra and other anti-inflammatory and regenerative proteins. The concentration of the lead substance IL-1Ra increases up to 140-fold compared to normal basal levels, said lead investigator Carsten Moser, MD.
Large multicenter trial
Moser and his colleagues performed a prospective, randomized, double-blind, placebo-controlled multicenter trial which included 376 patients with knee OA with an intent-to-treat analysis. Patients received treatment from October 2003 to February 2005, and were randomized to receive injections of one of the following:
- 2 ml of autologous conditioned serum (ACS) six times, twice a week, for 3 consecutive weeks (134);
- hyaluronan (HA) in a series of three injections given once a week (135); or
- saline, given as three injections in 3 weeks (107).
Follow-up exams were conducted at 6 weeks, 3 and 6 months, and 2 years.
The average overall patient age was 56.6 years. There were 31 dropouts, eight in both the ACS and saline groups and 15 in the HA group; however, all participants received at least one intra-articular injection of his or her assigned treatment.
The main reasons for dropping out of the study included local adverse events, lack of response, loss to follow-up and withdrawal of consent, he said.
Clinical gains from serum
According to the study abstract, patients with knee OA treated by ACS injection showed significant clinical improvements during the 26-week study compared to HA and saline injections on all scales.
The Visual Analog Scale (VAS) of pain was lowest in the ACS group associated with the largest reduction in VAS. The pain on weight-bearing decreased after the ACS injections from mean scores of 70.2 mm to 30.3 mm at week 13, and 30.4 mm at week 26.
The mean decrease for patients treated with HA and placebo was less than half in the ACS group. For example at week 26, the treatment difference between ACS and HA was 21.8 mm, and the difference between ACS and placebo was 22.5 mm.
The differences between the ACS group and the HA and placebo groups were highly statistically significant, favoring the ACS treatment (P<0.001) at weeks 7, 13 and 26.
Researchers found no significant difference between the HA and saline groups. The mean reduction of pain intensity in the HA and saline groups on the WOMAC scale were less than half that of the ACS group.
However, reductions in pain intensity in the targeted knees in the HA and placebo groups were similar (P>0.05), and there was no statistically significant difference between the HA group and placebo group at all time points (P>0.05).
Two-year results were available for 89.9% of participants. The investigators excluded patients who had received subsequent pharmacologic or surgical treatment for their OA. According to the abstract, there were still statistically significant differences at 2-year follow-up between the ACS group and the HA and saline groups.
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In the autologous conditioned serum procedure, investigators withdrew blood from the patient and incubated it for 6 to 9 hours at 37°C. They then reinjected the cell-free serum. Images: Orthogen, Düsseldorf | ||
For more information:Reference:
- Carsten Moser, MD, medical manager at Orthogen Lab Services, can be reached at Orthogen AG, Graf Adolf Strasse 43, D-40210 Düsseldorf, Germany; +49-211-387004; Fax: +49-211-3870010; e-mail: CarstenMoser@neue-orthopaedie.de; www.orthogen.com.
- Moser C, Baltzer AW, Wehling P, et al. Treatment of knee osteoarthritis with autologous conditioned serum (ACS): A prospective, randomized, placebo-controlled, patient- and observer-blind, parallel-design trial. #F802. Presented at the 8th European Federation of National Associations of Orthopaedics and Traumatology Congress. May 11-15, 2007. Florence.