A Randomized, Double Blind, Two Arms, Controlled Phase I/II Safety and Efficacy Study on MesoCellA-Ortho Tissue Engineered Product Intraarticularly Administrated in Adult Patients with Osteoarthrosis

Phase 1

• Conditions: articular knee diseases; MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-005000-17-PL
• Lead Sponsor: Jagiellonian University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.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.
2.Pregnant or breastfeeding women.
3.Allergy or poor tolerance of hyaluronic acid.
4.Diabetes mellitus type 1, diabetes mellitus type 2 on insulin treatment.
5.Lack of medical consultation in case of patients with diabetes group.
6.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).
7.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).
8.Current or medical history of the patient concerning carrier state or diseases: i)HIV, syphilis, HBV, HCV
ii) CMV, mycoplasmas (only subjects with positive results for IgM antibodies will be excluded)
iii) medical history or diagnosed during anamnesis/medical examination: EBV, malaria, Toxoplasma gondii, Trypanosoma cruzi, HTLV.
9.Symptomatic sciatica with radiation of pain to the examined limb.
10.Symptomatic osteoarthritis of the hip of both limbs.
11.Significant knee injuries within 6 months such as: ligament injuries, distal femur fracture or proximal tibia fracture, arthrofibrosis or cyclops lesions.
12.Endoprosthesis of the hip or knee joints.
13.Partial / total knee or hip joints replacement planned during the study.
14.Surgical operation of the lower limbs (including arthroscopy) within 6 months before screening visit or planned during the study.
15.Constant use of orthopaedic aids.
16.Intolerance or hypersensitivity to any component of the preparation.
17.Use of alternative treatment methods i.e. acupuncture within 4 weeks before screening visit or planning their use during the study.
18.Use in the treatment of osteoarthritis:
•Hyaluronates (injections - test knee) within 3 months
•Corticosteroids (injections) within 3 months
•Oral corticosteroids within 3 months
19.At screening:
•blood test result outside of the allowable ranges (e. g. morphology, electrolytes, blood clotting APTT, INR, fibrinogen, CRP, glucose)
•positive results of laboratory blood test (HIV, syphilis, HBV, HCV, CMV-IgM, mycoplasmas-IgM)
20.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.
21.Known allergic reactions to antibiotics used in cell culture: penicillin, streptomycin, amphotericin B.
22.Intolerance or hypersensitivity to any of the anesthetics (including lignocaine).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified