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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05344157




Registration number
NCT05344157
Ethics application status
Date submitted
4/04/2022
Date registered
25/04/2022
Date last updated
19/03/2024

Titles & IDs
Public title
A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
Scientific 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 a10ß1 (XSTEM-OA) in Adult Patients With Symptomatic Knee Osteoarthritis
Secondary ID [1] 0 0
XIN-XSTEM-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - XSTEM-OA

Experimental: XSTEM-OA - Single intra-articular injection of XSTEM-OA


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: Adverse events (AEs)
Timepoint [1] 0 0
From start of study until 18 months after injection
Primary outcome [2] 0 0
Safety and tolerability: 12-lead electrocardiogram (ECG)
Timepoint [2] 0 0
From start of study until 18 months after injection
Primary outcome [3] 0 0
Safety and tolerability: Laboratory examinations
Timepoint [3] 0 0
From start of study until 18 months after injection
Primary outcome [4] 0 0
Safety and tolerability: Physical examinations
Timepoint [4] 0 0
From start of study until 18 months after injection
Primary outcome [5] 0 0
Safety and tolerability: Vital signs
Timepoint [5] 0 0
From start of study until 18 months after injection
Secondary outcome [1] 0 0
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
Timepoint [1] 0 0
From start of study until 18 months after injection
Secondary outcome [2] 0 0
Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline
Timepoint [2] 0 0
From start of study until 18 months after injection
Secondary outcome [3] 0 0
Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline
Timepoint [3] 0 0
From start of study until 18 months after injection
Secondary outcome [4] 0 0
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
Timepoint [4] 0 0
From start of study until 18 months after injection
Secondary outcome [5] 0 0
Preliminary efficacy: Change in cartilage structure and morphology compared to baseline, based on MRI assessment of cartilage volume and composition
Timepoint [5] 0 0
From start of study until 18 months after injection
Secondary outcome [6] 0 0
Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)
Timepoint [6] 0 0
From start of study until 18 months after injection
Secondary outcome [7] 0 0
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis
Timepoint [7] 0 0
From start of study until 18 months after injection
Secondary outcome [8] 0 0
Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline
Timepoint [8] 0 0
From start of study until 18 months after injection

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xindu Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Xintela AB
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05344157
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Per Norlén, MD, PhD
Address 0 0
Xintela AB
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries