Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Ther… (NCT05081921) | Clinical Trial Compass
CompletedPhase 1/2
Clinical Trial to Evaluate Safety and Efficacy of MesoCellA-Ortho Tissue-Engineered Advanced Therapy Product in Patients With Osteoarthrosis and Civilisation Diseases
Poland192 participantsStarted 2022-01-05
Plain-language summary
The aim of the study is to evaluate safety, tolerability and clinical efficacy of a newly developed MesoCellA-Ortho tissue-engineered advanced therapy medicinal product in adult patients suffering with osteoarthritis and additionally burdened with other civilisation diseases such as type 2 diabetes and/ or obesity.
The active substance of MesoCellA-Ortho consists of in vitro expanded autologous human adipose tissue-derived mesenchymal stem/ stromal cells (AT-MSCs) resuspended in carrier solution for intraarticular injections for individual patents.
Who can participate
Age range40 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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.
What they're measuring
1
Nature, incidence and severity of adverse events (AEs)
Timeframe: Month 6 Follow-up
2
Change in Numerical Rating Scale (NRS)
Timeframe: Month 3 and Month 6 Follow-up
3
Change in joint swelling
Timeframe: Month 3 and Month 6 Follow-up
4
Change in the 36-Item Short Form Survey (SF-36)
Timeframe: Month 6 Follow-up
5
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Timeframe: Month 3 and Month 6 Follow-up
6
Change in the International Knee Documentation Committee (IKDC 2000)
✕. 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: 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).
✕. Current or medical history of the patient concerning carrier state or diseases: HIV, syphilis, HBV, HCV, EBV.