Osteoarthritis, KneePhase 1/2NCT05344157
A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
A Phase 1/2 study testing XSTEM-OA in people with Osteoarthritis, Knee, run by Xindu Pty Ltd at 2 sites in Australia.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- XSTEM-OA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesAustralia
- Study dates
- 22 Jun 2022to 18 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Genesis Research Services
Broadmeadow, New South Wales, 2292
Emeritus Research
Camberwell, Victoria, 3124
About this study
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
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- XSTEM-OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSTEM-OABiological
XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| XSTEM-OA | Experimental | Single intra-articular injection of XSTEM-OA Receives: Biological: XSTEM-OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events (AEs)
Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From start of study until 24 months after injection
Safety and tolerability: 12-lead electrocardiogram (ECG)
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Measured: From start of study until 18 months after injection
Safety and tolerability: Laboratory examinations
Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Measured: From start of study until 18 months after injection
Safety and tolerability: Physical examinations
Changes in physical examination compared to baseline.
Measured: From start of study until 18 months after injection
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.
Measured: From start of study until 18 months after injection
Secondary outcomes (8)
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
Measured: From start of study until 18 months after injection
Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline
Measured: From start of study until 18 months after injection
Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline
Measured: From start of study until 18 months after injection
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
Measured: 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
Measured: 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)
Measured: From start of study until 18 months after injection
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis
Measured: From start of study until 18 months after injection
Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline
Measured: From start of study until 18 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start22 Jun 2022
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xindu Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xintela AB
- Responsible party
- Sponsor
- Investigators
- Per Norlén, MD, PhD, Study director, Xintela ABStephen Hall, Dr, Principal investigator, Emeritus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344157
- Sponsor's protocol ID
- XIN-XSTEM-101
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2022
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05344157
- Acronym / sponsor ID
- XIN-XSTEM-101
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Xindu Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xintela AB
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XSTEM-OA | Experimental | Biological: XSTEM-OASingle intra-articular injection of XSTEM-OA |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XSTEM-OAXSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis. | Biological | XSTEM-OA |
Primary outcome
Safety and tolerability: Adverse events (AEs)
Time frame: 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: 12-lead electrocardiogram (ECG)
Time frame: From start of study until 18 months after injection
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Safety and tolerability: Laboratory examinations
Time frame: 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: Physical examinations
Time frame: From start of study until 18 months after injection
Changes in physical examination compared to baseline.
Safety and tolerability: Vital signs
Time frame: 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.
8 secondary outcomes
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
Time frame: From start of study until 18 months after injection
Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline
Time frame: From start of study until 18 months after injection
Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline
Time frame: From start of study until 18 months after injection
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
Time frame: 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
Time frame: 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)
Time frame: From start of study until 18 months after injection
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovitis
Time frame: From start of study until 18 months after injection
Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline
Time frame: From start of study until 18 months after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Norlén, MD, PhD study director
Xintela AB
Stephen Hall, Dr principal investigator
Emeritus Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XSTEM-OA in people with Osteoarthritis, Knee, run by Xindu Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability: Adverse events (AEs) (time frame: From start of study until 24 months after injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.