Status:
RECRUITING
Intravenous Infusion of hMSC100 (hUC-MSC) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
Lead Sponsor:
Help Therapeutics
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Osteoporosis in Post-menopausal Women
Osteoporosis
Eligibility:
FEMALE
45-85 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of human umbilical cord-derived mesenchymal stem cells for injection (hMSC100) in postmenopausal women with osteoporosis ...
Eligibility Criteria
Inclusion
- All of the following criteria must be met for inclusion:
- 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);
- Meets the diagnostic criteria for osteoporosis, exhibiting at least one of the following:
- Sustained a fragility fracture within the past 2 years;
- Suffered a fracture while receiving anti-osteoporosis medication;
- History of multiple-site fractures (including vertebral, hip, proximal humerus, or distal radius, etc.);
- 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;
- High risk of falling;
- Calculated by FRAX (Fracture Risk Assessment Tool), a 10-year risk of major osteoporotic fracture \>30% or hip fracture risk \>4.5%;
- Currently using medications known to cause skeletal harm \[such as high-dose glucocorticoids (prednisolone ≥7.5 mg/day for over 3 months), etc.\].
Exclusion
- 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.
- 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:
- Treatment with any PTH analog within the past 6 months (including participation in clinical trials of similar products);
- Treatment with any RANKL inhibitor (such as denosumab) within the past year;
- 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.
- DXA measurement: ① Fewer than two lumbar vertebrae were measurable by DXA; ② Height, weight, or body size may impede accurate DXA measurement.
- HBV-DNA ≥1,000 copies (cps)/mL or above the upper limit of normal; hepatitis C virus (HCV) antibody positive and HCV RNA copies above the upper limit of normal; positive syphilis antibody, or HIV antibody.
- Malabsorption syndromes, such as Crohn's disease and chronic pancreatitis. Known impaired absorption of calcium or vitamin D.
- History of neurological or psychiatric disorders.
- Current uncontrolled thyroid disease, hyperthyroidism, or hypothyroidism; thyroid stimulating hormone (TSH) level below normal range; TSH elevated (\>5.5 μIU/mL but ≤10.0 μIU/mL) and serum T4 outside the normal range; TSH \>10.0 μIU/mL.
- Known severe hepatic insufficiency (AST or ALT ≥2×ULN, ALP or total bilirubin ≥1.5×ULN), liver cirrhosis, unstable liver disease, or known clinically significant biliary anomalies as judged by the investigator (excluding Gilbert's syndrome or asymptomatic gallstones); known moderate to severe chronic kidney disease (eGFR \<60 mL/min/1.73 m²).
- Evidence of alcohol abuse or drug abuse within 12 months before screening, as determined by the investigator, may interfere with the understanding or completion of the study by the participant.
- Participation in another clinical trial within 6 months before screening.
- Other conditions deemed by the investigator as unsuitable for participation.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06949137
Start Date
May 1 2025
End Date
December 1 2027
Last Update
April 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
HelpThera
Nanjing, Jiangsu, China, 210000