EUCTR2019-005000-17-PL进行中（未招募）1 期
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 个研究点目标入组 200 人开始时间: 2021年7月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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