Table 5.
Clinical trials of cartilage repair with UC-MSCs or their secretome.
| Pathology | Source | Study design | Delivery mode | Patients (N°) | Results | Ref. |
|---|---|---|---|---|---|---|
| OA | Human UC-MSCs | Randomized, double-blind, controlled phase I/II | Intra-articular injection of 20 × 106 UC-MSCs once or twice vs. HA injection | 29 | Double injection group showed significant amelioration of pain and disability at 6 and 12 months of follow-up compared to HA group. No severe adverse events were reported. | Matas et al., 2019 [167] |
| Human UC-MSCs | Open-label, single arm, phase I/II | Injection of 10 × 106 UC-MSCs in 2 mL secretome + 2 mL HA | 29 | Significant reduction of the pain and greatest improvement in knee function after 6th-month follow-up. | Dilogo et al., 2020 [168] | |
| AM/UC particulate | Single-center, investigator-initiated, retrospective study | Inta-articular injection of 100 mg of AM/UC particulate | 42 | Significant clinical improvement of pain and function in patients with moderate to severe knee OA, with the potential to delay total knee replacement for up to 12 months | Mead et al., 2020 [169] | |
| RA | Human UC-MSCs | Prospective phase I/II study | Intravenous injection of 2 × 107 UC-MSCs | 64 | Lower levels of serological markers ESR, CRP, RF at 1 and 3 years and anti-CCP at 3 years after treatment. Decrease of health and joint function indexes 1 and 3 years after treatment. | Wang et al., 2019 [170] |
| Human UC-MSCs | Phase I/II study | Intravenous drip of 4 × 107 UC-MSCs and intravenous injection of 24 mg of cervus and cucumis peptides | 119 | Significant reduction of serological markers ESR, CRP, RF, and anti-CCP and improvement of health index and joint function index 1 year after treatment | Qi et al., 2020 [171] | |
| Human UC-MSCs | Randomized, controlled phase 1/2 | Intravenous infusion of 1 × 106 cells/kg of body weight with or without a single intramuscular infusion of 1 million IU of IFN-γ | 63 | Efficacy and ACR20 response rates attained in 53.3% patients with UC-MSCs alone and in 93.3% patients with UC-MSCs combined with IFN-γ at 3-month follow-up. No new or unexpected safety issues in 1-year follow-up | He et al., 2020 [172] |
ACR20: American College of Rheumatology 20; AM/UC: amniotic membrane/umbilical cord; CCP: cyclic citrullinated peptide (CCP) antibody; CRP: C-reactive protein; ESR: the erythrocyte sedimentation rate; HA: hyaluronic acid; OA: osteoarthritis; RA: rheumatoid arthritis; RF: rheumatoid factor.