Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteo… (NCT06949137) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
China9 participantsStarted 2025-06-20
Plain-language summary
The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (HMM910 ) in postmenopausal women with osteoporosis who are at high risk of fracture.
Who can participate
Age range45 Years – 85 Years
SexFEMALE
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Inclusion criteria
✓. Willingness to participate in the clinical trial and signing of informed consent;
✓. Female, age between 45 (inclusive) and 85 (inclusive) years, with primary menopause for ≥2 years;
✓. Body weight ≥40 kg, and body mass index (BMI) between 18 kg/m² (inclusive) and 30 kg/m² (inclusive);
✓. Those who meet the diagnostic criteria for osteoporosis and have one of the following conditions: ①Fragile fracture occurred in the past 2 years; ② Suffered a fracture while receiving anti-osteoporosis medication; ③ History of multiple-site fractures (including vertebral, hip, proximal humerus, or distal radius, etc.); ④ Bone mineral density (BMD) T-score \< -3.0 at the lumbar spine (L1-L4) or hip (total hip or femoral neck) as measured by DXA; ⑤ High risk of falling; ⑥ Calculated by FRAX (Fracture Risk Assessment Tool), a 10-year risk of major osteoporotic fracture \>30% or hip fracture risk \>4.5%; ⑦ Currently using medications known to cause skeletal harm \[such as high-dose glucocorticoids (prednisolone ≥7.5 mg/day for over 3 months), etc.\].
Exclusion criteria
✕. Diseases affecting bone metabolism: various metabolic bone diseases such as osteogenesis imperfecta and osteomalacia; Paget's disease of bone, hypercalcemia, hypocalcemia (participants must not have used calcium supplements within 24 hours before blood sampling for serum calcium screening); Cushing's syndrome, hyperprolactinemia; hypopituitarism; acromegaly, etc.; hyperparathyroidism or hypoparathyroidism; secondary menopause, etc.
✕. Secondary osteoporosis and other severe conditions, such as primary bone tumors (e.g., multiple myeloma, osteosarcoma, chondrosarcoma), secondary bone tumors, hematologic malignancies, or drug-induced osteoporosis.
✕. Current malignancy, history of malignancy not cured for at least 5 years, or disability due to severe or long-term diseases (such as stroke, Parkinson's disease, multiple sclerosis) resulting in inability to ambulate.
What they're measuring
1
Incidence and Severity of Treatment-Related Adverse Events
✕. Severe infectious diseases, autoimmune diseases (e.g., systemic lupus erythematosus), uncontrolled severe hypertension, or diabetes mellitus with severe complications or unstable blood glucose; severe cardiovascular, cerebrovascular, or other significant diseases.
✕. Allergic constitution: known allergy to products derived from mammalian cells or to the investigational product of clinical significance.
✕. Patients who have undergone major organ or bone marrow transplantation; patients who have received external radiation or skeletal implantation of radioactive materials.
✕. Patients who have previously received any form of cell therapy.
✕. Previous treatment with anti-osteoporosis drugs or medications affecting bone metabolism: ①Treatment with any PTH analog within the past 6 months (including participation in clinical trials of similar products); ② Treatment with any RANKL inhibitor (such as denosumab) within the past year; ③ Cumulative use of oral bisphosphonates for ≥3 years; or cumulative use \>3 months but \<3 years with the last dose administered within 6 months before screening, or intravenous bisphosphonate use within 24 months before screening.