A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05344157
• Other study ID #: XIN-XSTEM-101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Xintela AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• XSTEM-OA
XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.

Locations

Country	Name	City	State
Australia	Genesis Research Services	Broadmeadow	New South Wales
Australia	Emeritus Research	Camberwell	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Xindu Pty Ltd	Xintela AB

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Adverse events (AEs)	Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)	From start of study until 18 months after injection
Primary	Safety and tolerability: 12-lead electrocardiogram (ECG)	Change in 12-lead electrocardiograms (ECGs) compared to baseline.	From start of study until 18 months after injection
Primary	Safety and tolerability: Laboratory examinations	Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.	From start of study until 18 months after injection
Primary	Safety and tolerability: Physical examinations	Changes in physical examination compared to baseline.	From start of study until 18 months after injection
Primary	Safety and tolerability: Vital signs	Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.	From start of study until 18 months after injection
Secondary	Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline		From start of study until 18 months after injection
Secondary	Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline		From start of study until 18 months after injection
Secondary	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
Secondary	Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline		From start of study until 18 months after injection
Secondary	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
Secondary	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
Secondary	Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis		From start of study until 18 months after injection
Secondary	Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline		From start of study until 18 months after injection