Physical frailty with oral frailty symptoms frailty, Mesenchymal stem cells
Conditions
Interventions
Harvesting of subcutaneous fat and blood samples, followed by administration of a specified cells
Sponsors
Tamura Yoshiaki
Project for the Promotion of Infrastructure Development for the Practical Application of Regenerative Medicine by AMED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who have received a sufficient explanation of this study and have given their own voluntary written consent after fully understanding it. 2. Those aged 60 to 85 at the time of signing the informed consent form. 3. Patients who are judged to be pre-frail or frail according to the J-CHS criteria. 4. Those who have been diagnosed with oral frailty according to the OF-5 criteria.
Exclusion criteria
Exclusion criteria: 1. Individuals with an MMSE score of less than 24 2. Individuals with severe complications such as renal dysfunction, hepatic dysfunction, heart disease, or hematologic disorders 3. Individuals diagnosed with diabetes whose blood glucose levels are deemed uncontrollable by a physician 4. Patients diagnosed with hypertension whose blood pressure is deemed uncontrollable by a physician 5. Individuals who have experienced unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, or transient ischemic attack within the past three months 6. Individuals with a known allergy to penicillin or streptomycin 7. Individuals with a current malignancy or a history of malignancy within five years prior to enrollment 8. Individuals with a history of drug or alcohol abuse within the past 24 months 9. Persons who test positive in infectious disease screening (HCV antibody, HBs antigen, HIV-1/2 antibody, HTLV-1/2, syphilis, or parvovirus B19) 10. Individuals deemed otherwise unsuitable for participation in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(adverse events, coagulation risk assessment, severity grade, and outcomes) | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE 4-meter walking time Chair stand test Grip strength EQ-5D score OF-5 assessment score Occlusal force Tongue pressure Tongue and lip motor function | — |
Countries
Japan
Contacts
Public ContactKanae Noda
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Outcome results
None listed