TABLE 1.
Recent clinical trials with allogeneic stem cell preparations for physical frailty in older persons (2019 and later). a
| SC preparation | Sponsor | Identifier | Main outcomes | Time frame | N c | Results or status |
|---|---|---|---|---|---|---|
| hBM-MSCs d | Longeveron (United States) | NCT02065245 | Safety e | 1 month | 15 | Safe |
| hBM-MSCs d | Longeveron (United States) | NCT02065245 | Efficacy f | 6 months | 30 | Positive |
| hBM-MSCs d | Longeveron (United States) | NCT03169231 | 6 MWD | 180 days | 150 | Completed |
| hBM-MSCs d | Longeveron (United States) | NCT02982915 | Vaccine adjuvant h | 12 months | 62 | September 2021 g |
| hBM-MSCs d | Longeveron (Japan) | jRCT2043200038 | 6 MWD | 180 days | 45 | NC |
| hvBM-MSCsg | VA’s ORD (United States) i | NCT05284604 | Adherence j | 6 months | 36 | June 2025 g |
| hUC-MSCs | Shanghai East Hosp (CHN) | NCT04314011 | Safety and Efficacy | 1 and 6 months | 30 | Completed |
| hUC-MSCs | Vinmec Research (VNM) k | NCT04919135 | Safety and Efficacy | 12 months | 44 | Not yet recruiting |
| hUC-MSCs | FOREM (United States) | NCT05018767 | Safety | 4 years | 20 | November 2025 g |
| hAD-MSCs l | Healeon Medical (United States) | NCT03514537 | Safety (Frailty) | 6 months | 200 | March 2023 g |
| GMFFP m | Maharaj Institute (United States) | NCT03458429 | Safety (Efficacy n ) | 24 M | 30 | February 2023 g |
Most of the studies were randomized controlled trials (see text for details).
Abbreviations: 6 MWD, 6-min walk distance; allo-hMSCs, allogeneic mesenchymal stem cells; FOREM, Foundation for Orthopaedics and Regenerative Medicine; hBM-MSCs, human bone-marrow mesenchymal SCs. Hosp, hospital. hUCM-SCs, human umbilical cord mesenchymal stem cells; NC, not communicated.
Number of participants.
Lomecel-B (also called “allo-hMSCs”).
Phase I safety trial, including frailty outcomes.
Phase II RCT, investigating 1-month safety and 6-month efficacy on aging frailty.
Primary completion date (past or estimated).
Phase II RCT, to test the efficacy of Lomecel-B to improve influenza vaccine responses (12 months), including an initial phase I safety trial (30 days). Vertebral hBM-MSCs.
Veterans Health Administration-Office of Research and Development.
Percentage of study visits attended.
Vinmec Research Institute of Stem Cell and Gene Technology (Vietnam).
Cellular Stromal Vascular Fraction, an autologous hAD-MSCs, preparation.
GCSG-Mobilized Fresh Frozen Plasma.
Frailty Index and other secondary outcomes.