Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture

What this trial studies

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.

Conditions in scope

• Osteoporosis in Post-menopausal Women
• Osteoporosis

Interventions

• Human Umbilical Cord-derived Mesenchymal stem cell (Biological) — Intravenous infusion of human mesenchymal stem cells (HMM910 ) at 20-25 drops per minute

Who can join

Women only · Ages 45 Years to 85 Years

Inclusion criteria

• 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 \[such as high-dose glucocorticoids (prednisolone ≥7.5 mg/day for over 3 months), etc.\].

Exclusion criteria

• 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE1
• Start date: 2025-06-20
• Primary completion: 2026-03-06
• Last update posted: 2026-02-10
• First posted: 2025-04-29

Sponsor & contact

Lead sponsor: HELP Therapeutics Co., Ltd. (Industry)

Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Incidence and Severity of Treatment-Related Adverse Events (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).

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