A Single-center, Open-label, Single-arm, 3+3 Dose-escalation Phase I Clinical Study to Evaluate Safety and Tolerability of hMSC100 (Human UC-MSC Injection) in Postmenopausal Women With Osteoporosis and at High Risk of Fracture

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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 who are at high risk of fracture.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
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• 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 \[such as high-dose glucocorticoids (prednisolone ≥7.5 mg/day for over 3 months), etc.\].

Locations
Other Locations
China
HelpThera
RECRUITING
Nanjing
Contact Information
Primary
Jiaxian Wang, MD, PhD
wangjx@helpsci.com.cn
+86-18565616060
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2027-12
Participants
Target number of participants: 18
Treatments
Experimental: Low Dose Group
6.0×10\^7
Experimental: Medium Dose Group
1.2×10\^8
Experimental: High Dose Group
2.4×10\^8
Sponsors
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Leads: Help Therapeutics

This content was sourced from clinicaltrials.gov