Evaluation of safety and efficacy of intra-articular knee transplantation of three consecutive doses of allogenic umbilical cord mesenchymal stromal cells in patients with knee osteoarthritis: interventional clinical trial, phase I/II

Royan Stem Cell Technology Company0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•40-70 years
•Unilateral knee osteoarthritis
•Kellgren and Lawrence grade of both knees between 2 and 3
•Evidence of x-ray imaging findings compatible with knee osteoarthritis
•knee pain for at least 4 months that has not responded to common medical and physical therapies.
•Visual analogue score = 4
•Informed consent

•Pregnancy or lactation
•Inflammatory or infectious arthritis
•Intra-articular injection during the last 2 months
•Body Mass Index = 35
•Haematological and biochemical analysis with significant alterations that contraindicates intervention
•Known and uncontrolled chronic disease (including diabetes (HbA1c = 8), heart failure (EF <45%), renal failure (Cr> 2), liver failure (AST, ALT> 100)
•History of any type of neoplasm
•Take aspirin one week before the cell injection
•History of coagulopathy or use of anticoagulants
•Positive viral tests (HIV, CMV, HTLV1 & 2, HBV, HCV)
•Having a movement disorder
•Having serious illnesses with a life expectancy of less than 1 year
•Drug or alcohol abuse
•History or clinical diagnosis of any psychological disorder
•Arthroscopy in the last 6 months
•Rheumatoid arthritis or other autoimmune diseases that affect the joints.
•Immunosuppression or taking systemic immunosuppressant
•Allergy to proteins or substances in culture medium (gentamicin, bovine or equine serum)
•History of corticosteroid use 3 months before enrolment
•Knee joint misalignment =15 degree

发起方

Royan Stem Cell Technology Company