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

NCT06949137 | Active Not Recruiting Phase 1

• 1 other identifier: JL , HL
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 (HMM910 ) in postmenopausal women with osteoporosis who are at high risk of fracture.

Conditions

Osteoporosis in Post-menopausal Women; Osteoporosis

Keywords

mesenchymal stem cell; osteooprpsis; post menopausal; intravenous; fracture; HMM910

Outcome Measures

Primary Outcomes (1)

• 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).

  Within 4 weeks after administration

Secondary Outcomes (2)

• 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.

Study Arms (3)

Low Dose Group

EXPERIMENTAL

6.0×10\^7

Biological: Human Umbilical Cord-derived Mesenchymal stem cell

Medium Dose Group

EXPERIMENTAL

1.2×10\^8

Biological: Human Umbilical Cord-derived Mesenchymal stem cell

High Dose Group

EXPERIMENTAL

2.4×10\^8

Biological: Human Umbilical Cord-derived Mesenchymal stem cell

Interventions

Human Umbilical Cord-derived Mesenchymal stem cell BIOLOGICAL

Intravenous infusion of human mesenchymal stem cells (HMM910 ) at 20-25 drops per minute

Also known as: HMM910

High Dose Group; Low Dose Group; Medium Dose Group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• HELP Therapeutics Co., Ltd.: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

HELP Therapeutics

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• Juan Li, MD, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

• Hua Lin, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: June 20, 2025
• Primary Completion: March 6, 2026
• Study Completion (Estimated): September 6, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: One year after study completed
• Access Criteria: 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.

Locations

CN (1)