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Table 1 Inclusion and exclusion criteria

From: Cartilage regeneration and inflammation modulation in knee osteoarthritis following injection of allogeneic adipose-derived mesenchymal stromal cells: a phase II, triple-blinded, placebo controlled, randomized trial

Inclusion criteria

Exclusion criteria

1. 18 < Age < 65

1. BMI \(>\) 35 kg/m2

2. Kellgren–Laurence grading: II or III

2. Immune deficiency

3. VAS Index Score \(\ge 3\)

3. Renal failure (Cr \(>\) 2 mg/dL)

4. Knee joint alignment \(<\) 30 degrees

4. Hepatitis B, C, HIV, HTLV1-2, CMV infections

5. Informed consent

5. Coagulopathy or using anticoagulant agents

 

6. Liver malfunction (ALT or AST \(>\) 100 IU/L)

 

7. Uncontrolled diabetes (HbA1c > 8.5%)

 

8. Heart diseases (EF < 45%)

 

9. Allergy to proteins or cultured substances

 

10. Pregnancy or lactation

 

11. Malignancy

 

12. Addiction

 

13. Concurrent corticosteroid therapy

 

14. Participating in another clinical trial

 

15. Unwillingness to cooperate in the study and follow-ups

  1. VAS visual analogue scale, BMI body mass index, Cr creatinine, ALT alanine aminotransferase, AST aspartate aminotransferase, HbA1c hemoglobin A1c, EF ejection fraction, CMV cytomegalovirus, HTLV1-2 human T-lymphotropic virus, HIV human immunodeficiency virus