Osteoporosis in Post-menopausal WomenPhase 1NCT06949137
Intravenous Infusion of Human Mesenchymal Stem Cells (HMM910 ) in Postmenopausal Women With Osteoporosis at High Risk of Fracture
A Phase 1 study testing Human Umbilical Cord-derived Mesenchymal stem cell in people with Osteoporosis in Post-menopausal Women and Osteoporosis, run by HELP Therapeutics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Osteoporosis in Post-menopausal Women, Osteoporosis
- What is being tested?
- Human Umbilical Cord-derived Mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 6 Sep 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.].
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Being tested
- Human Umbilical Cord-derived Mesenchymal stem cell
- Keywords
- mesenchymal stem cell, osteooprpsis, post menopausal, intravenous, fracture, HMM910
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord-derived Mesenchymal stem cellBiological
Also called HMM910
Intravenous infusion of human mesenchymal stem cells (HMM910 ) at 20-25 drops per minute
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Group | Experimental | 6.0×10^7 Receives: Biological: Human Umbilical Cord-derived Mesenchymal stem cell |
| Medium Dose Group | Experimental | 1.2×10^8 Receives: Biological: Human Umbilical Cord-derived Mesenchymal stem cell |
| High Dose Group | Experimental | 2.4×10^8 Receives: Biological: Human Umbilical Cord-derived Mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Related Adverse Events
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).
Measured: Within 4 weeks after administration
Secondary outcomes (2)
Pharmacokinetic (PK) Assessment of hMSC100 Target Gene Levels
To evaluate the pharmacokinetic profile of hMSC100, the levels of the hMSC100 target gene will be measured at various time points before and after stem cell treatment. PK parameters will be calculated if data allows.
Measured: From enrollment to the end of treatment at 20 weeks
Change from Baseline in Bone Turnover Markers and Estrogen Levels
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start20 Jun 2025
- Primary completion6 Mar 2026 (estimated)
- Study completion6 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis in Post-menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
- Investigators
- Juan Li, MD, PhD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolHua Lin, MD, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949137
- Sponsor's protocol ID
- JL , HL
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of the trial will be disseminated to study participants through direct consultation with a trial clinician at completion of the trial, as well as through the publication of results.