IL-1ra
IL-1β
IL-6
TNFa
IL-10
FGFb
VEGF
HGF1
IGF1
PDGF AB
TGFβ1
No. of patients
224
224
200
92
92
92
92
92
92
92
80
Concentration (pg/mL) prior to incubation (0 h)
Basal (b)
236
<3.9
<12.5
<15.6
<7.8
14.6
61
431
86,000
205
1165.0
Concentration (pg/mL) after incubation (6 h)
Mean
2014.8
7.9
28.7
10.1
33.4
26.6
508.6
1339.3
117,208.8
39,025.6
97,393.0
SD
4381.1
8.7
48.1
9.6
18.9
20.8
307.7
928.7
51,644.4
10,515.8
113,418.3
Minimum
390.3
1.4
0.9
3.0
4.1
2.8
114.1
691.4
37,430.0
19,601.0
13,067.0
Maximum
31,057.0
48.9
250.2
69.7
105.0
104.5
1694.0
6473.0
440,000.0
66,208.0
823,000.0
45.4 Production of “Orthokine” ACS Is Illustrated in Fig. 45.1
Venous blood in different amount depends on the number of injections needed to the treated pathology, between six injections for osteoarthritis in a big joint and three injections to spine or tendinopathy. Ten milliliters of venous blood is drawn in each special device containing glass spheres (usually one tube (10 mL of blood) is needed to yield factors for each injection) is incubated for 6–9 h at 37 °C. Then the blood is centrifuged and cell free ACS is withdrawn, injected immediately or stored in deep freezer (≤18 °C, up to 12 months) until treatment.
Fig. 45.1
Cell-free autologous conditioned serum (ACS) is generated by incubation of aseptically aspirated venous blood with a specialized syringe in the presence of medical-grade glass spheres. Peripheral blood leukocytes produce elevated amounts of numerous endogenous anti-inflammatory cytokines, such as interleukin-1 receptor antagonist, that are recovered with the serum. Following centrifugation and portioning, ACS is stored or aseptically injected into the affected region of the human (or animal) subject. In randomized controlled human clinical trials, injections were given in a series of three injections once weekly for spinal applications or six injections twice weekly for the treatment of osteoarthritis
The content of different factors in the plasma is shown in Table 45.1.
45.5 ACS (Orthokine): Recommendations for Indication, Dosage, and Way of Treatment in Orthopedic Pathologies
These recommendations provide guidelines about injection, number of injections, frequency, dosage, timing, and indications: ACS/ORTHOKINE therapy is always injected with 0.2 μm bacterial filter.
Large joints: knee–hip–shoulder–ankle–osteoarthritis—“frozen shoulder”: no local anesthetic, six injections, 2–4 mL, 2(−3)/weekly.
Small joints: first carpometacarpal joint, acromioclavicular joint, metacarpophalangeal joints—osteoarthritis—traumatic injuries, no local anesthetic, six injections, 0.5–2.5 mL, 2(−3)/weekly.
Tendinopathy: tendon/ligament/injuries: jumpers knee—epicondylitis, one to three needles with NaCl on the insertion of the tendon, no local anesthetic four injections, 2–4 mL, 1–2/weekly.
Subacromial: rotator cuff, 1 needle with NaCl, no local anesthetic, four injections, 2–4 mL, 1–2/weekly.
Achillodynia: partial rupture Achilles tendon, three needles with NaCl between paratendon next to the tendon, no or slightly local anesthetic, four injections, 2–4 mL, 1–2/weekly.
Post-op: joints: knee, post-arthroscopy, post-ACL OP—after reconstructive cartilage surgery (OATS, micro fracture, ACT) start 4–6 weeks post-op, one needle, slightly local anesthetic, four injections, 0.5–2.5 mL, 1/weekly.
Post-op: tendon: shoulder, Achilles tendon, rotar cuff reconstruction—Achilles tendon suture begin 4–6 weeks post OP, one to three needles, slightly local anesthetic, four injections, 0.5–2.5 mL, 1/weekly.
Sports injuries: muscle injuries—bundle fissure – contusion, five to seven needles with NaCl following the muscle string, no local anesthetics, five to six injections, 2/5–5 mL, 3/weekly.
Lumbar spine: stenosis, sciatica, facet arthrosis, radiculopathy, to inject epidural space, transforaminal, intraforaminal, periradicular, facet joints, three injections, 2–4 mL, 1–3/weekly.
45.6 Side Effects and Contraindications
As for now, there is no information about any serious side effect caused by the Orthokine treatment. There are no known incompatibilities between Orthokine-ACS and other drugs such as NSAID.
Orthokine-ACS should not be premixed with other compounds. In particular, it is unclear how local anaesthetics may interact with the proteins in Orthokine-ACS.
No information are available regarding the treatment with Orthokine-ACS during pregnancy and lactation or in infants and children.
Orthokine-ACS is 100% autologous material. It is used for local injections. Unwanted effects have been observed very rarely at the same frequency as in placebo injection (physiologic saline).
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