Osteoporotic fracture
Conditions
Interventions
1:Cell solvent intravenous infusion
2:Intravenous infusion of rFib cells
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. In line with the "2017 Chinese Medical Association Osteoporosis and Bone Mineral Disease Branch Primary Osteoporosis Diagnosis and Treatment Guidelines" moderate to severe osteoporosis diagnostic criteria; 2. Patients with no significant improvement in osteoporosis symptoms after treatment with anti-osteoporosis drugs for more than 1 year; 3. Bone density check, T value 60 years old; 5. Osteoporotic fractures of the thoracolumbar vertebrae require surgical treatment; 6. The patient has not taken anti-osteoporosis or drugs that affect the activity of bone cells in the past 3 months; 7. Subjects who voluntarily signed the informed consent form for this research and followed the research process; 8. The researcher determines that the subject meets the test requirements based on the patient's medical history, physical examination, laboratory examination, etc.; 9. The patient returns to the hospital on time for review or telephone follow-up after treatment.
Exclusion criteria
Exclusion criteria: 1. People with serious basic diseases such as severe cardiovascular, lung, liver, kidney, hematopoietic system diseases and mental illness; 2. Those with uncontrolled diabetes or hypertension; 3. Hematology test HIV is positive, TP, hepatitis A antibody, hepatitis B antibody, hepatitis C antibody are positive; patients with infectious diseases such as Ureaplasma gonorrhea, Chlamydia, Mycoplasma hominis antibody are positive or highly suspected of having tumors; 4. Anemia, severe bleeding tendency or coagulopathy; 5. Patients with spinal cord, nerve, and blood vessel injuries; 6. Patients with secondary osteoporotic fractures; 7. Those who are known or suspected to be allergic to cell preparations, or have a history of specific reactions; 8. Pregnant and lactating women; 9. Women and men who have a plan to conceive in the past year; 10. Patients with a history of prescription drug abuse, illegal drug abuse and alcohol abuse within 6 months before screening; 11. Patients who quit smoking and drinking during the test cannot be guaranteed; 12. Participated in other clinical trials within 3 months before screening; 13. Those who are unwilling to obtain full-thickness skin for cell culture during surgery; 14. Patients with orthopedic internal fixation rejection after surgery; 15. Postoperative patients have poor fracture reduction, unstable fixation or other surgical-related vascular and neurological complications; 16. Any situation that the investigator believes may cause participation in the study to be inconsistent with the subjects' best interests or may prevent, restrict or confuse the safety or effectiveness assessment of the protocol; 17. Those who do not have the ability to make independent judgments or sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of bone clinical healing time;Serum osteocalcin (osteocalcin, OC);Serum type I procollagen N-terminal propeptide;Serum type I collagen C-terminal peptide cross-linking;Pain VAS score;Isokinetic muscle strength measurement;Osteoporosis Symptom Grading Table;Evaluation of bone clinical healing quality;Whole body bone density;Serum alkaline phosphatase (ALP);Functional recovery score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other fracture assessment; | — |
Countries
China
Contacts
Public ContactFei He
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed