Table 2.
Other Registered Human Trails on Stem Cell Therapy for Frailty
| Trials ID | Start year | Status | Phase | Condition or disease | Age/sex | Enrollment number | Intervention | Cells dose/patient | Delivery | Follow-up time frame | Primary outcome indicators | Secondary outcome indicators |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01501461 | 2011 | Withdrawn | Not applicable (open-label, nonrandomized) | Frailty syndrome | 55–90 years/all | 0 | Auto-ADSCs | Not applicable | Single intravenous injection | 1. 3 months 2. 6 months |
1. Improvement in PPT 2. Number of Aes 3. Improved BC/BD 4. Quality of life |
Exercise capacity |
| NCT02982915 | 2016 | Recruiting | Phase I/II (double blind, randomized) | Aging frailty | 65–90 years/all | 43 | Allo-BMMSCs; co-injecting with fluzone high dose vaccine | 2 × 107; 1 × 108 | Single peripheral intravenous infusion | 1. 1 and 4 weeks postvaccination 2. 30 days 3. 6 months 4. 12 months |
1. Incidence of TE-SAEs 2. Adaptive immunity 3. Primary B cell response |
1. Postvaccination changes 2. Changes of biomarkers 3. Different decline rate from aging frailty 4. Death from any cause |
| NCT03169231 | 2017 | Recruiting | Phase IIb (double blind, randomized, parallel assignment) | Aging frailty | 70–85 years/all | 120 | Allo-BMMSCs | 2.5 × 107; 5 × 107; 1 × 108; Placebo. | Single peripheral intravenous infusion | 6 months | 6MWT | 1. Physical function capacity using PROMIS-PF-SF 20a 2. Serum TNF-α |
AEs, adverse events; Auto-ADSCs, autologous adipose-derived stem cells; BC/BD, body composition/bone density; PROMIS-PF-SF 20a, Patient-Reported Outcome Measurement-Physical Function-Short Form 20a; TE-SAEs, treatment-emergent serious adverse events.