NCT06949137进行中（未招募）1 期
A Single-center, Open-label, Single-arm, 3+3 Dose-escalation Phase I Clinical Study to Evaluate Safety and Tolerability of HMM910(Human Mesenchymal Stem Cells Injection) in Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Help Therapeutics1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2025年6月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Treatment-Related Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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);
- •Those who meet the diagnostic criteria for osteoporosis and have one of the following conditions: ① Fragile 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.].
排除标准
- •Subjects who meet one or more of the following criteria will be excluded:
- •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: ① Treatment 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.
- •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.
研究组 & 干预措施
Low Dose Group
Experimental
6.0×10^7
干预措施: Human Umbilical Cord-derived Mesenchymal stem cell (Biological)
Medium Dose Group
Experimental
1.2×10^8
干预措施: Human Umbilical Cord-derived Mesenchymal stem cell (Biological)
High Dose Group
Experimental
2.4×10^8
干预措施: Human Umbilical Cord-derived Mesenchymal stem cell (Biological)
结局指标
主要结局
Incidence and Severity of Treatment-Related Adverse Events
时间窗: Within 4 weeks after administration
Any adverse reactions/adverse events (AEs) related to MSC treatment occurring within 4 weeks after the completion of MSC administration in all subjects, and their severity (graded according to CTCAE criteria).
次要结局
- Pharmacokinetic (PK) Assessment of hMSC100 Target Gene Levels(From enrollment to the end of treatment at 20 weeks)
- Change from Baseline in Bone Turnover Markers and Estrogen Levels(Bone turnover markers: At Day 3, and Weeks 1, 2, 4, 8, 16, and 20 after the first treatment. Estrogen levels: At Weeks 2, 4, and 20 after the first treatment.)
研究者
研究点 (1)
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