Table 5.
Non-randomized prospective clinical trials.
| Bakowski et al. (Bakowski et al., 2021) (Poland) | Knee OA NR Pro/auto lipoaspirate | 37 | IDKC2000, KOOS, NPRS, WOMAC; Satisfaction in Stage II but not Stage IV; 27 mo follow up; No SAE |
| Barfod & Blond (Barfod and Blond, 2019) (Denmark) NCT02697682 | Knee OA NR Pro/Auto MFAT (Lipogems) | 20 | KOOS, VAS; Significant improvement vs baseline up to 12 mo; No SAE |
| Bistolfi et al. (Bistolfi et al., 2021) (Italy) | Knee OA NR Retro/Auto MFAT (Lipogems or Lipocells) | 78 | FJS, KOOS, KSS, LS, NRS; Significant improvement vs baseline av. 23.5 mo follow up; No SAE (knee swelling, minor venous thrombosis) |
| Boric et al. (Boric et al., 2019) (Croatia) ISRCTN13337022 |
Knee OA NR Pro/Auto MFAT (Lipogems) | 10 | dGEMRIC, VAS; Significant improvement vs baseline up to 24 mo |
| Chen et al. (Chen et al., 2021) (Taiwan) NCT03007576 | Knee OA NR Pro/Auto IPF ASC (50 × 106 single injection) | 12 | IKDC 2000, KOOS, MOCART, VAS, WOMAC; Significant improvement vs baseline up to 11 mo follow up; No SAE |
| Dall'Oca et al. (Dall'Oca et al., 2019) (Italy) | Hip OA NR Pro/Auto MFAT (Lipogems) | 6 | HHS, WOMAC, VAS; Improvement vs baseline; 6 mo follow up; No SAE (one hematoma @ lipo site) |
| Freitag et al. (Freitag et al., 2020c) (Australia) ACTRN12617000638336 | OA Knee CT NR Pro/Auto ASC (50 × 106 per knee at 0 and 6 mo) | 27 | KOOS, MRI, MOCART, NPRS, PGIC, WOMAC; Significant improvement vs baseline with 36 mo follow up; No SAE |
| Haas et al. (Haas et al., 2020) (Germany) | Thumb Carpometacarpal OA NR Pro/Auto MFAT (Luer Lock) | 89 | MHQ; Significant improvement vs baseline at 12 mo follow up; No SAE |
| Hudetz et al. (Hudetz et al., 2019) (Croatia) | Knee OA NR Pro/Auto MFAT (Lipogems) | 20 | KOOS, VAS, WOMAC; Significant improvement vs baseline up to 12 mo; No SAE |
| Malanga et al. (Malanga et al., 2021) (USA) NCT03714659 | Knee OA NR Pro/Auto MFAT (Lipogems) | 20 | KOOS, NPRS; Significant improvement vs baseline up to 12 mo follow up; No SAE (swelling/bruising at lipo site (Niada et al., 2019) or injection site (Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment Guidance for Industry, 2018)) |
| Mayoly et al. (Mayoly et al., 2019) (France) NCT03164122/EudraCT #2016-002648-18 | Wrist OA NR Pro/Auto MFAT (Hapifat) + PRP | 3 | DASH, PRWE, VAS; Significant improvement vs baseline up to 12 mo; No SAE (pain reported at adipose harvest site) |
| Natali et al. (Natali et al., 2021) (Italy) | Ankle OA NR Pro/Auto MFAT (Lipogems) | 31 | AOFAS, FADI, VAS; Significant improvement vs baseline up to 24 mo follow up; No SAE |
| Tsubosaka et al. (Tsubosaka et al., 2020) (Japan) | Knee OA NR Pro/Auto SVF (Cytori) (25 × 106 at 0 mo) | 57 | KOOS, MRI, VAS, WOMAC; Improvement vs baseline av. 13.4 mo; No SAE |
Abbreviations: Allo, Allogeneic; AOFAS, American Orthopaedic Foot and Ankle Society (AOFAS) scale; ASC, Adipose-derived Stromal/stem Cells; Auto, Autologous; B, Blinded; BMAC, Bone Marrow Aspirate Concentrate; CR, Case Report; CS, Case Series; CT, Controlled Trial; DASH, Disabilities of the Arm and Shoulders; dGEMRIC, Delayed Gadolinium Enhanced MRI of Cartilage; FJS, Forgotten Joint Scale; HA, Hyaluronate; HHS, Harris Hip Score; IKDC 2000, International Knee Documentation Committee 2000; KOOS, Knee Injury and Osteoarthritis Outcome Score; LS, Lysholm Score; MFAT, Microfragmented Adipose Tissue; MHQ, Michigan Hand Outcomes Questionnaire; MOCART, MRI Observation of Cartilage Repair Tissue; NPRS, Numeric Pain Rating Scale; NR, Not Randomized; NRS, Noise Reporting Scale; PGIC, Patient Global Impression of Change; Pro, Prospective; PRP, Platelet Rich Plasma; PRWE, Patient-Related Wrist Evaluation; R, Randomized; Retro, Retrospective; SAE, Serious Adverse Event; SVF, Stromal Vascular Fraction Cells; TBCR, To Be Conducted/Reported, VAS, Visual Analog Scale; WOMAC, Western Ontario and McMasters Universities Osteoarthritis Index.