Intra-articular transplantation of umbilical cord stromal mesenchymal cells in patients with knee osteoarthritis

Phase 1

Recruiting

Conditions: Knee Osteoarthritis.
Osteoarthritis of knee

Registration Number: IRCT20211102052944N1

Lead Sponsor: Royan Stem Cell Technology Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire.

Secondary Outcome Measures

Name	Time	Method
Visual analog scale. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale Questionnaire.;Western Ontario and McMaster Universities Osteoarthritis Index. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: ?WOMAC Questionnaire.;Disability index. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Short Form Health-36 Questionnaire.;Articular cartilage thickness. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Magnetic resonance imaging.