Table 1.
Summary of clinical trials using MSCs and scaffolds for bone regeneration from 2018 to 2023.
| Cells | Scaffolds | Condition | Number of Patients (Age) | Number of Cells Seeded (Scaffolds Dimensions) | Follow Up | Control | Evaluation Methods and Outcomes | References |
|---|---|---|---|---|---|---|---|---|
| Autologous bone marrow-derived MSCs | ß-tricalcium phosphate (TCP) | Lumbar degenerative disc disease (DDD) at L4-L5 or L5-S1 | 11 (18–65) | 1.5 × 10−6 cells/kg from the patient (20 mL of TCP) | 1, 3, 6, 12, 60 months | _ | Radiography and clinical evaluation revealed that 80% of patients achieved lumbar fusion in up to five years. Both the visual analog scale (VAS) and the Oswestry disability index (ODI) improved after surgery. The Short-Form Health Survey (SF-36) evaluated the physical and mental status that showed a significant improvement in the first year after surgery. There were no adverse effects related to cell implantation. | Blanco et al., 2019 [35] |
| MSCs obtained from the dental pulp of two male patients ages 7 and 8 and a 10-year-old patient (hDPSCs) |
Scaffold of lyophilized collagen-polyvinylpyrrolidone sponge (Fibroquel; Aspid, Mexico City, Mexico) |
Deep infra bony defect ≥ 4 mm deep caused by periodontal disease | 22 (55–64) | 5 × 106 hDPSCs (0.5 cm2) | 6 months | 11 scaffolds without hDPSCs | Increase in the bone mineral density of the alveolar bone; increased salivary superoxide-dismutase and decreased levels of salivary IL1β | Beatriz Hernández-Monjaraz et al., 2020 [36] |
| Autologous bone marrow-derived MSCs | Biphasic calcium phosphate granules (BCP) | Maxillofacial bone defects | 11 (52–79) | 20 × 106 cells (1 cm3) |
1, 2, 4,12 months | _ | All patients had successful ridge augmentation and an adequate amount of bone for dental implant installation without adverse events. The alveolar ridge increased both in width and volume. | Gjerde et al., 2018 [37] |
| Autologous bone marrow-derived MSCs | ß -tricalcium phosphate (TCP) | Femoral bone defect | 37 (44–75) | 15 ± 4.5 × 106 cells (dimensions not reported) | 6 weeks, 3, 6, 12 months | Group A: 19 patients with ß -TCP and autologous MSC, group B: 19 patients with ß -TCP alone, group C: 19 patients with cancellous allografts only | The combination between TCP and MSCs appears safe and promotes the healing of bone defects. No significant differences were observed between groups A and B. Significant differences were observed between group B and C. Adverse events emerged from the demanding and extensive character of revision hip replacement without a causal relationship to the suspension of autologous MSCs. | Pavel Sponer et al., 2018 [38] |
| Autologous bone marrow-derived MSCs | Biphasic calcium phosphate bioceramic granules (BCP) | Long bone non-unions (fractures of the femur, tibia, and humerus) | 28 (3 months), 27 (6 months), 25 (12 months) (18–65). E. Gómez-Barrena et al., 2020 [25] 26 (18–65). E. Gómez-Barrena et al., 2020 [26] 28 (18–65). E. Gómez-Barrena et al., 2020 [27] |
20 × 106 cells (5–10 cc of bioceramic granules) | 3, 6, 12 months For E. Gómez-Barrena et al., 2020 [27] subgroup analysis of gender, tobacco use, time since the original fracture |
_ | The ATMP combined with the bioceramic was surgically delivered to the non-unions, and 26/28 treated patients were found radiologically healed at one year (3 out of 4 cortices with bone bridging). E. Gómez-Barrena et al., 2020 [25] The REBORNE bone healing score, defined to perform an evaluation of long bone non-union consolidation in radiograph and computed tomography (CT), proved valid to assess consolidation against CT measurements with a concordance correlation of 79% and an accuracy based on ROC curves of 83%. E. Gómez-Barrena et al., 2020 [26] The clinical and radiological evaluation confirmed bone consolidation at 3 months (25%), 6 months (67.8%), and 12 months (92.8%), with lower consolidation scores in smokers. Femur, humerus, and tibia showed consolidation at one year. E. Gómez-Barrena et al., 2020 [27] |
E. Gómez-Barrena et al., 2020 [39] E. Gómez-Barrena et al., 2020 [40] E. Gómez-Barrena et al., 2020 [41] |
| Bone marrow-derived MSCs from donor | Medical grade bioceramic granules of beta-tricalcium phosphate by ChronOS (Synthes GmbH, Oberdorf) placed between specially moulded plastic scaffolds (PLA such as 70:30 polyia (L-lactide-co-D,L-lactide) and insert the sandwich into the skull. | Cranial defect <80 mm diameter | 10 (18–80) | Not reported | 12 months | _ | Quantitative bone density of the tissue-engineered construct and adjacent bone from CT scan at 12 months. Assessment of cosmesis by photography. NO outcomes |
No publication, no results posted estimated study completion date 2017 |