Clinical trial NCT05344157: A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
Official title: A First-in-Human Open-Label Phase 1/2a Study to Evaluate Safety, Tolerability and Efficacy of a Single Intra-Articular Injection of Allogeneic Mesenchymal Stem Cells Selected for Integrin α10β1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Xintela AB
Sponsor class: INDUSTRY
Collaborators: name: Xintela AB
First posted: 2022-04-25
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety and tolerability: Adverse events (AEs)
timeFrame: From start of study until 24 months after injection
measure: Safety and tolerability: 12-lead electrocardiogram (ECG)
timeFrame: From start of study until 18 months after injection
measure: Safety and tolerability: Laboratory examinations
timeFrame: From start of study until 18 months after injection
measure: Safety and tolerability: Physical examinations
timeFrame: From start of study until 18 months after injection
measure: Safety and tolerability: Vital signs
timeFrame: From start of study until 18 months after injection
Secondary outcomes:
measure: Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis
timeFrame: From start of study until 18 months after injection
measure: Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline
timeFrame: From start of study until 18 months after injection
Other outcomes:
measure: Exploratory outcome: Change in Visual Analogue Scale (VAS) for pain compared to baseline
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in KOOS compared to baseline
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in EQ-5D-5L compared to baseline
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in 40 m fast paced walk test compared to baseline
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in whole knee health compared to baseline, based on MRI
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis
timeFrame: 24 months after injection
measure: Exploratory outcome: Change in joint space narrowing based on x-ray compared to baseline
timeFrame: 24 months after injection
Locations:
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
Study officials:
affiliation: Xintela AB
name: Per Norlén, MD, PhD
role: STUDY_DIRECTOR
affiliation: Emeritus Research
name: Stephen Hall, Dr
role: PRINCIPAL_INVESTIGATOR
References: