Sarcopenia-osteoporosis syndrome
Conditions
Interventions
Experimental group:The drug is allogeneic human bone marrow mesenchymal stem cell injection, administered intravenously at a dose of 1×10^8 cells per infusion, once monthly for a total of four doses.
Sponsors
Guangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical research; the patient or their legal guardian fully understands and is informed of the research and signs the informed consent form; willing to follow and complete all research procedures. 2. Age>= 60 years and 35 kg and unwilling or unable to undergo regular resistance exercise training during the study period. 6. Patients with osteoporosis who are not suitable for current conventional treatment due to personal circumstances (e.g., chronic renal insufficiency, hypercalcemia), or those who are currently or only suitable for treatment with active vitamin D and its analogues.
Exclusion criteria
Exclusion criteria: 1. Allergy to known components of the drug (the main component of this product is bone marrow mesenchymal stem cells, and the excipients include dimethyl sulfoxide, human serum albumin, etc.). 2. Patients with advanced liver disease or renal failure. 3. Grade III-IV congestive heart failure. 4. History of myocardial infarction within 6 months. 5. Patients with hypertension or hyperglycemia whose blood pressure or blood sugar remains 25% above the normal range despite standard treatment (normal blood sugar: fasting blood sugar 3.9-6.1 mmol/L, blood sugar 2 hours after meal <7.8 mmol/L; normal daytime blood pressure <135/85 mmHg, normal nighttime blood pressure 120/70 mmHg). 6. History of malignant tumors. 7. History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases. 8. Patients with active infections (including positive hepatitis B virus antigen, positive hepatitis C virus antibody, or positive PPD test). 9. Patients with deep vein thrombosis at screening or a history of pulmonary embolism within 3 months before screening. 10. Patients with grade III or IV pulmonary arterial hypertension (World Health Organization [WHO] functional classification) at screening. 11. Patients using zoledronic acid, parathyroid hormone (such as teriparatide), or RANKL monoclonal antibody for osteoporosis treatment. 12. Patients who have received stem cell therapy before. 13. Patients who have participated in other interventional clinical studies within 3 months or 5 half-lives (only for experimental drug intervention, whichever is longer) before infusion. 14. Patients with any other factors that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in bone density compared to the baseline;The changes in muscle content of the limbs compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse reactions associated with stem cell infusion;Incidence of all adverse events related to the study drug during the study period;Changes in the five indicators of osteoporosis compared to the baseline value;The change in grip strength when compared to the baseline;The change in walking speed of 6 meters compared to the baseline;The change in weight compared to the baseline value;The visual analogue scale (VAS) score for pain and the changes compared to the baseline;The changes in the Basic Activity of Daily Living (BADL) score compared to the baseline;Changes in serum inflammatory factors compared to the baseline level; | — |
Countries
China
Contacts
Public ContactWang Hong
Guangzhou First People's Hospital
Outcome results
None listed