Osteoporosis
Conditions
Interventions
Cell therapy group:Regenerative fibroblasts are prepared as cell agents and used for therapy by intravenous injection
Traditional therapy group:Traditional method
Sponsors
Kunming University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with primary osteoporosis, including those with brittle fracture (the fracture without trauma or only with minor trauma), or those diagnosed with osteoporosis by measuring bone mineral density (T score of bone mineral density detected by Dual Energy X-ray Absorptiometry (DXA) is lower or equal to -2.5 SD); 2. Male or female aged > 40 years; 3. No other anti-osteoporotic drugs are used in patients or such drugs were used before but have been discontinued for more than 12 weeks; 4. Patients have no birth plan in the immediate future; 5. Patients who are voluntary to enjoy the study and agree to sign informed consent certificates and follow the study process; 6. The researchers determine that the patients meet the study requirements according to the allround physical examination, laboratory examination, examination of vital signs, etc; 7. Patients suffer from joint injury (such as osteonecrosis of the femoral head).
Exclusion criteria
Exclusion criteria: 1. Patients have the disease that causes difficulties in skin wound healing; 2. Hematological examination shows at least one positive result: HIV antibody, HbsAg, Treponema pallidum (TP), HAV- antibody, HCV-antibody; 3. Poor physical condition, dysfunction of major organs such as cardiovascular system, respiratory system, liver, kidney, etc; 4. Patients with severe underlying disease; 5. Patients are known or suspected to be allergic to cell agents or have a history of specific adverse reaction to cell agents; 6. Patients have been received chemotherapy or radiotherapy within 6 months before the study; 7. Patients have a history of prescription drug abuse and a history of illegal drug abuse within 6 months before the study; 8. Patients have a history of alcohol abuse within 6 months before the study; 9. Patients can not guarantee to quit smoking and drinking alcohol during the study; 10. Patients have undergone major surgery (ie need general anesthesia) within 12 weeks before the study or have not yet completely recovered from surgery or are expected to undergo surgery unrelated to this clinical study during the study period; 11. Patients participate in other clinical trials within 3 months before the study; 12. Researchers believe that participation in the study is not in the best interest of the patients or there are any cases that may prevent, limit or confuse the assessment of safety or effectiveness of this study; 13. Patients refuse to sign informed consent certificates (including but not limited to donor's informed consent, subject's informed consent and informed consent certificates of surgical operation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density;Markers of bone turnover ; | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical symptomatic grading;imageological examination;SF-36 Health Survey Scales; | — |
Countries
China
Contacts
Public ContactWu Haiying
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed