Table 4.
Authors/reference/nation Clinical trials or national registration # |
Study type/therapy/device | Subject # | Metrics, outcomes & serious adverse events (adverse events) |
---|---|---|---|
Freitag et al. (Freitag et al., 2020a) (Australia) | Ankle OA CR/Auto ASC (20 to 50 × 106 ASC at 0, 6, 12 mo) | 1 | FADI, MRI; Improvement vs baseline up to 24 mo; No SAE |
Freitag et al. (Freitag et al., 2020b) (Australia) ACTRN12617000638336 |
OA Knee CS NR Pro/Auto ASC (50 × 106 per knee at 0 and 6 mo) | 8 | KOOS, MRI, WOMAC; Improvements with 24 mo follow up; No SAE |
Gobbi et al. (Gobbi et al., 2021) (Italy, United Arab Emirates, USA) | Knee OA NR Retro/Auto MFAT (Lipogems) | 75 | KOOS; Significant improvement vs baseline up to 24 mo follow up; No SAE (49 % pain at lipo site, 37 % bruising at lipo site, 13 % knee swelling) |
Lapuente et al. (Lapuente et al., 2020) (Spain) | Knee OA NR Retro/Auto SVF | 50 | Serum Cytokines, Ultra, VAS, WOMAC; Significant improvement vs baseline at 12 mo follow up; No SAE |
Mautner et al. (Mautner et al., 2019) (USA) | OA Knee NR Retro/Auto BMAC or MFAT/Lipogems | 76 | Emory QLF, KOOS, VAS; Significant improvement pre vs post with >1 yr follow up; No SAE |
Vinet-Jones & Darr (Vinet-Jones and Darr, 2020) (USA) | OA Shoulder CS NR Pro/Auto MFAT (Lipogems) | 25 | DASH, Rad, VAS; Significant improvement vs baseline at 12 mo follow up; No SAE |
Abbreviations: Allo, Allogeneic; 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, Shoulder and Hand; Emory QLF, Emory Quality of Life; FADI, Foot and Ankle Disability Index; HA, Hyaluronate; KOOS, Knee Injury and Osteoarthritis Outcome Score; MFAT, Microfragmented Adipose Tissue; MRI, Magnetic Resonance Imaging; NR, Not Randomized; Pro, Prospective; PRP, Platelet Rich Plasma; R, Randomized; Rad, Radiography; Retro, Retrospective; SAE, Serious Adverse Event; SVF, Stromal Vascular Fraction Cells; TBCR, To Be Conducted/Reported; Ultra, Ultrasound; VAS, Visual Analog Scale; WOMAC, Western Ontario and McMasters Universities Osteoarthritis Index.