Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases

Prior treatment

• Current or medical history of the patient: inflammatory diseases of the joints (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative arthritis involving the spine joints, septic arthritis, prior diagnosis of target arthrosis with crystal precipitation or elevated CRP in the condition, inflammation), osteonecrosis, osteoporotic fractures or other painful joint diseases other than osteoarthritis; secondary causes of osteoarthritis (e.g. rheumatoid arthritis, fibromyalgia, birth defects).
• Symptomatic sciatica with radiation of pain to the examined limb.
• Surgical operation of the lower limbs (including arthroscopy) within 6 months before screening visit or planned during the study.
• Use of alternative treatment methods i.e. acupuncture within 4 weeks before screening visit or planning their use during the study.
• Use in the treatment of osteoarthritis:
  • Hyaluronates (injections - test knee) within 3 months
  • Corticosteroids (injections) within 3 months
  • Oral corticosteroids within 3 months
• Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.

Other illness

• A history of cancer for 2 years before screening. In case of history of cancer medical above 2 years, consultation with oncologist and her/his permission for participation in clinical trial will be obligatory.
• Allergy or poor tolerance of hyaluronic acid.
• Diabetes mellitus type 1, diabetes mellitus type 2 on insulin treatment.
• Lack of medical consultation in case of patients with diabetes group.
• Comorbidities significantly affecting overall health (e.g. history of myocardial infarction, heart failure, thrombophlebitis, arterial hypertension (hypertensive crises), chronic obstructive pulmonary disease, renal failure, liver failure, advanced atherosclerosis, psychoorganic syndrome, hemiparesis, history of stroke).
• Current or medical history of the patient concerning carrier state or diseases: HIV, syphilis, HBV, HCV, EBV.
• Intolerance or hypersensitivity to any component of the preparation.
• Known allergic reactions to antibiotics used in cell culture: penicillin, streptomycin, amphotericin B.
• Intolerance or hypersensitivity to any of the anesthetics (including lignocaine).

Lab values

• If available, recent (\<14 days) blood tests results outside of the allowable ranges (e. g. morphology, electrolytes, blood clotting APTT, INR, fibrinogen, CRP, glucose) if significant for participation in clinical study, particularly regarding contraindication for liposuction procedure.
• If available, positive results of laboratory blood tests (HIV, syphilis, HBV, HCV, CMV -IgM antibodies, mycoplasmas -IgM antibodies, toxoplasmosis IgM antibodies, EBV IgM antibodies) if significant for participation in clinical study, particularly regarding contraindication for liposuction procedure.

Other

• Pregnant or breastfeeding women.
• Symptomatic osteoarthritis of the hip of both limbs.
• Significant knee injuries within 6 months such as: ligament injuries, distal femur fracture or proximal tibia fracture, arthrofibrosis or cyclops lesions.
• Endoprosthesis of the hip or knee joints.
• Partial / total knee or hip joints replacement planned during the study.
• Constant use of orthopaedic aids.

• Knee cartilage lesions (osteoarthritis II/III grade in Kellgren-Lawrence scale confirmed in X-ray)
• Age between 40-70 years (inclusive)
• No contraindications for liposuction
• No contraindications for the general use of biological treatment, stem cells, PRP and whole autologous blood
• Availability to take part into all study visits, barring unforeseen circumstances
• Able and willing to perform exercises at home given by a physiotherapist
• Contraceptive (birth control pills, injection, pessary or intrauterine device (IUD), spermicide condoms)
• The pain intensity in treated knee not lower than grade 3 (on 11-point Numerical Rating Scale)