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©The Author(s) 2023.
World J Stem Cells. Mar 26, 2023; 15(3): 31-51
Published online Mar 26, 2023. doi: 10.4252/wjsc.v15.i3.31
Published online Mar 26, 2023. doi: 10.4252/wjsc.v15.i3.31
Table 3 Dental stem cell-based clinical trials registered at clinicaltrials.gov
Ref. | Registration ID | Status | Diseases | Study design | Cell source | Administration route | Number of patients | Interventions | Follow-upperiod | Phase | Outcomes | |
Test group | Control group | |||||||||||
- | NCT04983225 | Recruiting | Periodontitis | Randomized; parallel assignment; double-blind (participant, investigator) | Dental pulp | Injecting into the periodontal defect site | 36 | DPSCs (1 × 106)/site; DPSCs (5 × 106)/site; DPSCs (3-4 × 107)/three or four sites; DPSCs (1 × 107)/site; DPSCs (2 × 107)/two sites | Saline solution | 90, 180, 360, 720 d | Phase 1 | |
- | NCT02523651 | Unknown | Periodontitis | Randomized; parallel assignment; triple-blind (participant, investigator, outcomes Assessor) | Allogeneic dental pulp | Injecting into the periodontal defect site | 40 | DPSCs (1 × 106) | Saline solution | 1 year | Phase 1/2 | |
- | NCT03386877 | Completed | Periodontitis | Randomized; parallel assignment; triple-blind (participant, investigator, outcomes assessor) | Autologous dental pulp | Delivering into intrabony defect via minimally invasive surgical technique | 29 | Micrografts of DPSCs + Collagen sponge | Collagen sponge | 6, 12 mo | Not applicable | |
- | NCT01082822 | Unknown | Periodontitis | Nonrandomized; parallel assignment; open label | Periodontal ligament | Implanted into bone defect sites via surgical approach | 80 | PDLSCs sheet fragment + DBBM (Bio-oss); PDLSCs sheet pellets + DBBM (Bio-oss); DBBM (Bio-oss) | Sham comparator | 4, 12, 24 wk; 1 year | Phase 1/2 | |
- | NCT03638154 | Completed | Periodontitis | Randomized; parallel assignment; double-blind (care provider, outcomes assessor) | Gingival | Implanted into bone defect sites via surgical approach | 20 | GFs + GMSCs + β-TCP | β-TCP | 1, 3, 7, 14 d; 6 mo | Not applicable | |
- | NCT03137979 | Unknown | Periodontitis | Randomized; parallel assignment | Gingival | Implanted into bone defect sites via surgical approach | 30 | GMSCs + Collagen scaffolds; collagen scaffolds | Open flap debridement | 1, 3, 6 mo | Phase1/2 | |
Chen et al[29], 2016 | NCT01357785 | Unknown | Periodontitis | Randomized; parallel assignment; open label | Autologous periodontal ligament | 35 | None | 3-12 mo | Phase1 | |||
Cubuk et al[62], 2023 | NCT04641533 | Completed | Post-extraction sockets | Split-mouth; randomized; crossover assignment; double-blind (investigator, outcomes assessor) | Dental pulp | Placing into the extraction socket | 13 | DPSCs + L-PRF | L-PRF | 7 d; 6 mo | Not applicable | |
- | NCT02731586 | Unknown | Edentulous alveolar ridge | Single group assignment; open label | Allogeneic dental pulp | Introducing dental pulp-derived mesenchymal stem cells during placement of dental implants | 10 | Dental pulp-derived MSCs | None | 3 mo | Early Phase 1 | |
Tanikawa et al[63], 2020; Pinheiro et al[70], 2019 | NCT03766217 | Completed | Cleft lip and palate | Randomized; parallel assignment; single-blind (outcomes assessor) | Autologous deciduous pulp | Placed into the alveolar defect via surgical approach | 62 | SHED + Hydroxyapatite-collagen sponge | Iliac crest autogenous bone graft | 15 d; 3, 6, 12 mo | Phase3 | |
Tanikawa et al[63], 2020 | NCT01932164 | Completed; Has results | Cleft lip and palate | Single group assignment; open label | Autologous deciduous pulp | Maxillary alveolar graft by tissue engineering | 5 | SHED + Hydroxyapatite-collagen sponge | None | 3, 6 mo | Not applicable | Percentage of bone filling at 6 mo postoperatively: 89.5% |
- | NCT04130100 | Unknown | Knee osteoarthritis | Randomized; parallel assignment; open label | Dental pulp | Intraarticular injection | 60 | Low dose of DPSCs; high dose of DPSCs | Sodium hyaluronate | 12 mo | Early phase 1 | |
- | NCT01814436 | Unknown | Dental pulp necrosis | Single group assignment;open label | Autologous deciduous pulp | 80 | Scaffold-free SHED-derived pellet | None | 3-12 mo | Not applicable | ||
- | NCT03957655 | Unknown | Liver cirrhosis | Randomized; parallel assignment; single-blind (outcomes assessor) | Autologous deciduous pulp | Peripheral vein infusion | 40 | SHED (1 × 106 cells/kg body weight) | Standard medication for viral hepatitis and cirrhosis | 4, 8, 12, 16, 24 wk | Early phase 1 | |
- | NCT03912480 | Unknown | Type 1 diabetes | Single group assignment; open label | Deciduous pulp | Intravenous drip | 24 | SHED (0.11 IU/kg body weight) + Insulin + oral hypoglycemic drugs | None | 1, 2, 6 wk; 2, 3, 6, 9, 12 mo | Early phase 1 | |
Suda et al[67], 2022 | NCT04608838 | Completed | Acute ischemic stroke | Randomized;Parallel assignment;Quadruple-blind (Participant, Care Provider, Investigator, Outcomes Assessor); | Allogeneic dental pulp | Intravenously infusion | 79 | DPSCs (JTR-161, 1 × 108 cells); DPSCs (JTR-161, 3 × 108 cells) | Placebo | 91, 366 d | Phase 1/2 | |
- | NCT02728115 | Active, not recruiting | Nonrandomized; parallel assignment; open label | Allogeneic deciduous pulp | Intravenous administration | 6 | SHED (Cellavita HD, 1 × 106 cells); SHED (Cellavita HD, 2 × 106 cells) | None | 1, 4 years | Phase 1 | ||
- | NCT04219241 | Active, not recruiting | Huntington’s disease | Single group assignment; open label | Allogeneic deciduous pulp | Intravenous administration | 35 | SHED (Cellavita HD, 2 × 106 cells) | None | 1, 2 years | Phase 2/3 | |
Wenceslau et al[71], 2022 | NCT03252535 | Completed | Huntington’s disease | Randomized; parallel assignment; triple-blind (participant, investigator, outcomes assessor) | Allogeneic deciduous pulp | Intravenous administration | 35 | SHED (Cellavita HD, 1 × 106 cells); SHED (Cellavita HD, 2 × 106 cells) | Physiological solution without cells | Monthly for 14 mo | Phase 2 | |
Ye et al[69], 2020 | NCT04336254 | Recruiting | COVID-19 | Randomized; parallel assignment; triple-blind (participant, investigator, outcomes assessor) | Allogeneic dental pulp | Intravenous injection | 20 | DPSCs (3 × 107 cells) | Saline | 28 d | Phase 1/2 | |
- | NCT04302519 | Unknown | COVID-19 | Single group assignment; open label | Dental pulp | Intravenous injection | 24 | DPSCs (1 × 107 cells/kg body weight) | None | 3, 7, 14, 28, 360 d | Early phase 1 |
- Citation: Song WP, Jin LY, Zhu MD, Wang H, Xia DS. Clinical trials using dental stem cells: 2022 update. World J Stem Cells 2023; 15(3): 31-51
- URL: https://www.wjgnet.com/1948-0210/full/v15/i3/31.htm
- DOI: https://dx.doi.org/10.4252/wjsc.v15.i3.31