Comparing the Therapeutic Potential of Stem Cells and their Secretory Products in Regenerative Medicine
Table 2
Completed clinical trials that evaluated the safety, efficacy, and feasibility of stem cell therapy.
Type of stem cell
Treated disease
Trial design
Number of cells
Route of administration
Outcomes
References
Pluripotent stem cells
Ischemic heart disease
An open label, phase I study to assess both the feasibility and safety of epicardial delivery of a fibrin gel embedded with human embryonic stem cell- (ESC-) derived CD15+ IsI-1+ progenitors
NA
Epicardial transplantation of cells embedded in fibrin patch
A follow-up of a phase I/II, open-label, nonrandomized, 4-cohort, dose escalation, multicenter clinical trial to evaluate the long-term safety and tolerability of human ESC-derived retinal pigment epithelium (hESC-RPE) cellular therapy
A phase I/II, open-label, nonrandomized, sequential, multicenter clinical trial to evaluate the safety and tolerability of hESC-RPE cellular therapy in patients with SMD and to evaluate potential efficacy endpoints to be used in future studies of hESC-RPE cellular therapy
A phase I/II, open-label, nonrandomized, sequential, multicenter clinical trial to evaluate the safety and tolerability of subretinal injection of hESC-RPE
A phase I/II trial, open-label, nonrandomized study to evaluate the long-term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry age-related macular degeneration from one to five years following the surgical procedure to implant the MA09-hRPE cells
A phase I/II trial, open-label, nonrandomized study to evaluate the long-term MA09-hRPE cellular therapy in patients with advanced Stargardt’s macular dystrophy from one to five years following the surgical procedure to implant the MA09-hRPE cells
A phase 1b study to evaluate the safety and feasibility, particularly with respect to adverse acute hemodynamic effects and profibrosis of MSC treatment
or hMSCs/kg
Intravenous infusion
Feasible and satisfactory short-term safety profile.
A randomized, controlled phase I/II clinical trial to evaluate the safety and efficacy of human umbilical cord-derived mesenchymal stem cells (UC-MSCs) encapsulated in a plasma-derived biomaterial for regenerative endodontic procedures in mature permanent teeth with apical lesions
A phase I/II study to evaluate the feasibility and safety of the implantation of 40 million BMSCs in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence)
A phase II trial to assess the feasibility, safety, and efficacy of trans-endocardial administration of autologous MSCs and cardiac progenitor cells (CPCs), alone, and in combination
A phase 1/2 randomized controlled trial to evaluate the safety and efficacy of the intravenous infusion of UC-MSCs in patients with chronic stable heart failure and reduced ejection fraction
MSCs/kg
NA
Safe and effective with improvement in quality of life
A phase 1 clinical trial to evaluate the safety of human UC-MSC infusion in the treatment of patients with moderate and severe COVID-19 pulmonary disease
of UC-MSCs
NA
Safe and well tolerated without serious adverse events