Status:
COMPLETED
A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
Lead Sponsor:
Xindu Pty Ltd
Collaborating Sponsors:
Xintela AB
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-OA when administered as a single intra-articular injection to patients with symptomatic knee osteoarthritis. Th...
Eligibility Criteria
Inclusion
- Major inclusion criteria:
- Aged ≥40 and ≤75 years at Screening
- Radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of KL grade II to III
- Moderate to severe pain associated with osteoarthritis in the knee as measured by a VAS pain score of ≥35 and ≤90 mm
- Major exclusion criteria:
- Body mass index (BMI) of ≥35 at Screening
- Ongoing signs or symptoms of systemic or local infection
- Known knee infection in the study knee within 6 months of Screening
- History of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery
- Medical history of any autoimmune disease
- History of surgery in the study knee that occured within 6 months of Screening
- Treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of Screening
- Patients who are immunocompromised as caused by a disease
Exclusion
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05344157
Start Date
June 22 2022
End Date
June 18 2025
Last Update
August 26 2025
Active Locations (2)
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1
Genesis Research Services
Broadmeadow, New South Wales, Australia, 2292
2
Emeritus Research
Camberwell, Victoria, Australia, 3124