Clinical trials using dental stem cells: 2022 update

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

DBBM: Deproteinized bovine bone mineral; GFs: Gingival fibroblast; PRF: Platelet-rich fibrin; TCP: Tricalcium phosphate; DPSCs: Dental pulp stem cells; SHED: Stem cells from exfoliated deciduous teeth.