Osteoarthritis, Knee
Conditions
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. The study is divided into two parts; a dose escalation (Part A) and an optional dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) may be further expanded in Part B.
Interventions
BIOLOGICALXSTEM-OA
XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.
Sponsors
Xintela AB
Xindu Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability: Adverse events (AEs) | From start of study until 24 months after injection | Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE) |
| Safety and tolerability: Vital signs | From start of study until 18 months after injection | Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature. |
| Safety and tolerability: Physical examinations | From start of study until 18 months after injection | Changes in physical examination compared to baseline. |
| Safety and tolerability: Laboratory examinations | From start of study until 18 months after injection | Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis. |
| Safety and tolerability: 12-lead electrocardiogram (ECG) | From start of study until 18 months after injection | Change in 12-lead electrocardiograms (ECGs) compared to baseline. |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline | From start of study until 18 months after injection |
| Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline | From start of study until 18 months after injection |
| Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline | From start of study until 18 months after injection |
| Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline | From start of study until 18 months after injection |
| Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition | From start of study until 18 months after injection |
| Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS) | From start of study until 18 months after injection |
| Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis | From start of study until 18 months after injection |
| Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline | From start of study until 18 months after injection |
Other
| Measure | Time frame |
|---|---|
| Exploratory outcome: Change in 40 m fast paced walk test compared to baseline | 24 months after injection |
| Exploratory outcome: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis | 24 months after injection |
| Exploratory outcome: Change in joint space narrowing based on x-ray compared to baseline | 24 months after injection |
| Exploratory outcome: Change in EQ-5D-5L compared to baseline | 24 months after injection |
| Exploratory outcome: Change in KOOS compared to baseline | 24 months after injection |
| Exploratory outcome: Change in Visual Analogue Scale (VAS) for pain compared to baseline | 24 months after injection |
| Exploratory outcome: Change in whole knee health compared to baseline, based on MRI | 24 months after injection |
| Exploratory outcome: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition | 24 months after injection |
Countries
Australia
Outcome results
None listed