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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05344157
Ethics application status
Date submitted
4/04/2022
Date registered
25/04/2022
Date last updated
17/04/2025

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
Treatment: Other - XSTEM-OA

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


Treatment: Other: 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
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: Adverse events (AEs)
Assessment method [1] 0 0
Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Timepoint [1] 0 0
From start of study until 24 months after injection
Primary outcome [2] 0 0
Safety and tolerability: 12-lead electrocardiogram (ECG)
Assessment method [2] 0 0
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Timepoint [2] 0 0
From start of study until 18 months after injection
Primary outcome [3] 0 0
Safety and tolerability: Laboratory examinations
Assessment method [3] 0 0
Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Timepoint [3] 0 0
From start of study until 18 months after injection
Primary outcome [4] 0 0
Safety and tolerability: Physical examinations
Assessment method [4] 0 0
Changes in physical examination compared to baseline.
Timepoint [4] 0 0
From start of study until 18 months after injection
Primary outcome [5] 0 0
Safety and tolerability: Vital signs
Assessment method [5] 0 0
Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.
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
Assessment method [1] 0 0
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
Assessment method [2] 0 0
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
Assessment method [3] 0 0
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
Assessment method [4] 0 0
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
Assessment method [5] 0 0
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)
Assessment method [6] 0 0
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
Assessment method [7] 0 0
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
Assessment method [8] 0 0
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
Not applicable
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
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
1/06/2025
Actual
Sample size
Target
24
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
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Xintela AB
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05344157