Osteoporosis
Conditions
Interventions
Treatment group:Intravenous infusion of autologous stem cell injection, a basic treatment composed of calcium and vitamin D
Control group:The basic treatment consisting of calcium supplements and vitamin D
Sponsors
Huzhou Center Hospital
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The donor must be 45 years old or above, with a BMI of [17,30]. 2. (Consultation) Gender is not limited. Females must have been menopausal (at least one year since the last menstrual period and clearly not in a pregnant/lactating state, or FSH>40 U/L). 3. Meet the diagnostic criteria for severe osteoporosis: Bone mineral density measured by dual energy X-ray absorptiometry (DXA) shows that the t-value at either the lumbar vertebrae (L1-4) or the proximal femur (femoral neck or total hip) is <=-2.5 accompanied by fragility fractures. 4. Meeting the criteria for individuals with extremely high fracture risk due to osteoporosis as stipulated in the "Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022)" : fractures still occur during the period of anti-osteoporosis drug treatment; 5. Previously, during the treatment with one or more of the anti-osteoporosis drugs recommended by clinical guidelines (teriparatide, zoledronic acid, desumab, romomumab and alendronate sodium, including combination therapy and sequential therapy containing the aforementioned drugs), osteoporotic fractures occurred and were identified as treatment failure, or treatment was terminated due to drug intolerance; 6. (Consultation) It has been more than three months since the last fracture at the time of screening. 7. Agree to discontinue the use of all drugs, procedures, physical therapies, Chinese herbal medicines and health products aimed at alleviating osteoporosis symptoms or treating osteoporosis during the study period, except for the symptomatic medications provided in this study and the items necessary for treating adverse events, as well as the drugs and treatment methods included in the contraindications of this study. 8. Agree to timely and truthfully record and provide feedback on combined medications and treatment items, including invasive treatments, during the treatment and follow-up observation period; 9. Agree not to receive other cell therapies or participate in other clinical trials or studies during the treatment and follow-up observation period of this study; 10. Voluntarily collect hair follicle tissues and venous blood for the preparation of human hair follicle mesenchymal stem cell injection, understand that the collected hair follicle tissues and venous blood will be used in the production of stem cell injection, and sign the relevant "Informed Consent Form"; 11. Agree to provide researchers with necessary health information for the preparation of human hair follicle mesenchymal stem cell injection, including previous disease history, family history of genetic diseases, family history of tumors, etc. Male study participants agreed to strictly use contraception for three months after the start of this study and the end of the follow-up period, while female study participants agreed not to undergo assisted reproduction for three months after the start of this study and the end of the follow-up period.
Exclusion criteria
Exclusion criteria: Study participants were excluded if they met one or more of the following criteria: 1. Patients with known genetic diseases; 2. (Inquiry) patients with malignant tumor disease or history of malignant tumor disease and cured less than 5 years; 3. (Inquiring) immunocompromised patients, including those taking immunosuppressants or organ transplantation; 4. (Inquiry) associated with diseases that may lead to systemic or local pathological fractures and bone destruction, such as ankylosis Spondylitis, bone tumor, osteosclerosis, osteitis deformity, osteochondrodysplasia, etc. 5. (inquiry) patients with uncured muscle-related diseases, such as myositis, myopathy and muscular dystrophy; 6. (Inquiry) Unable to walk independently for any reason, fracture within the past 3 months, unconventional continuous bedridden or use crutches, wheelchairs and other tools for walking for more than 1 month due to trauma, disease or surgery within the past 6 months, and external fixation of lower limbs within the past 6 months; 7. (Inquiry) receipt of bisphosphonates, denosumab, parathyroid hormone analogues, calcitonin, estrogen therapy, or selective estrogen receptor modulators within 2 years before study entry; 8. (Asking) those who live alone or have a history of repeated falls; 9. (inquiry) dizzy with blood or needles; 10. (Inquiry) with uncontrolled neuroendocrine diseases, including primary or secondary hyperparathyroidism, hyperthyroidism, hypopituitarism, hypercalciuria, etc. 11. (Inquiry) suffering from serious gastrointestinal diseases, such as gastrointestinal fistula, pancreatic exocrine dysfunction, etc. 12. (Inquiry) patients with uncontrolled asthma, a history of interstitial lung disease, moderate-to-severe COPD or respiratory failure, and a history of hospitalization due to acute exacerbation of COPD; 13. (Inquiry) complicated with uncontrollable systemic or local infectious diseases; 14. Suffering from severe neurological or psychiatric diseases, including dementia, epilepsy, cerebrovascular disease, peripheral neuropathy, demyelinating disease, anorexia nervotica, bulimia nervotica, etc. 15. Those who have not been cured of tuberculosis, or have a history of syphilis or HIV; 16. Abnormal body temperature (ear temperature >=37.3? or =160 mmHg, or diastolic blood pressure =90 mmHg after taking antihypertensive drugs; 3) patients with ACS in the past 2 years or angina pectoris in the past 6 months; 19. The blood system meets any of the following: 1) history of hemorrhagic or thrombotic diseases, or severe hematological diseases; 2) hemoglobin =3 times upper limit of normal; 3) ALP>=
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Determination by dual energy X-ray absorptiometry; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count;Urinalysis; | — |
Countries
China
Contacts
Public ContactQiu Wei
Huzhou Central Hospital
Outcome results
None listed