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 - BioMiStem-CT

Jagiellonian University0 sites200 target enrollmentJuly 15, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Jagiellonian University
Enrollment: 200
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 15, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Jagiellonian University

Eligibility Criteria

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:

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.