A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
XSTEM-OA
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- Genesis Research Services
- Emeritus ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XSTEM-OA
Arm Description
Single intra-articular injection of XSTEM-OA
Outcomes
Primary Outcome Measures
Safety and tolerability: Adverse events (AEs)
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)
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Safety and tolerability: Laboratory examinations
Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Safety and tolerability: Physical examinations
Changes in physical examination compared to baseline.
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.
Secondary Outcome Measures
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
Preliminary efficacy: Changes in Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline
Preliminary efficacy: Change in EuroQoL 5 Dimension 5 Level test (EQ-5D-5L) compared to baseline
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
Preliminary efficacy: Change in cartilage structure compared to baseline, based on MRI assessment of cartilage volume and composition
Preliminary efficacy: Change in whole knee health compared to baseline, based on MRI assessment by the MRI Osteoarthritis Knee Score (MOAKS)
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovial thickness and synovial blood flow
Preliminary efficacy: Changes in joint space narrowing based on x-ray compared to baseline
Full Information
NCT ID
NCT05344157
First Posted
April 4, 2022
Last Updated
December 2, 2022
Sponsor
Xindu Pty Ltd
Collaborators
Xintela AB
1. Study Identification
Unique Protocol Identification Number
NCT05344157
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xindu Pty Ltd
Collaborators
Xintela AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 a dose expansion part (Part: B). Three dose levels are planned to be evaluated in Part A and selected dose level(s) will be further expanded in Part B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XSTEM-OA
Arm Type
Experimental
Arm Description
Single intra-articular injection of XSTEM-OA
Intervention Type
Biological
Intervention Name(s)
XSTEM-OA
Intervention Description
XSTEM-OA is an allogeneic, adipose tissue-derived, integrin alpha10beta1-selected and expanded mesenchymal stem cell (MSC) product for the treatment of osteoarthritis.
Primary Outcome Measure Information:
Title
Safety and tolerability: Adverse events (AEs)
Description
Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
From start of study until 18 months after injection
Title
Safety and tolerability: 12-lead electrocardiogram (ECG)
Description
Change in 12-lead electrocardiograms (ECGs) compared to baseline.
Time Frame
From start of study until 18 months after injection
Title
Safety and tolerability: Laboratory examinations
Description
Changes in laboratory tests compared to baseline. The clinical laboratory tests include haematology, chemistry, coagulation and urinalysis.
Time Frame
From start of study until 18 months after injection
Title
Safety and tolerability: Physical examinations
Description
Changes in physical examination compared to baseline.
Time Frame
From start of study until 18 months after injection
Title
Safety and tolerability: Vital signs
Description
Changes in vital signs compared to baseline. Vital signs include blood pressure, pulse rate, respiratory rate and oral body temperature.
Time Frame
From start of study until 18 months after injection
Secondary Outcome Measure Information:
Title
Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline
Time Frame
From start of study until 18 months after injection
Title
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
Title
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
Title
Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline
Time Frame
From start of study until 18 months after injection
Title
Preliminary efficacy: Change in cartilage structure compared to baseline, based on MRI assessment of cartilage volume and composition
Time Frame
From start of study until 18 months after injection
Title
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
Title
Preliminary efficacy: Change in inflammatory activity compared to baseline, based on MRI assessment of synovial thickness and synovial blood flow
Time Frame
From start of study until 18 months after injection
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central contact
Phone
+46 (0)734 122045
Email
clinicaltrials@xintela.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Norlén, MD, PhD
Organizational Affiliation
Xintela AB
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen Hall, Dr
Organizational Affiliation
Emeritus Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
+61 (02) 4985 1860
Email
natalie@genesisresearchservices.com
First Name & Middle Initial & Last Name & Degree
Marc Russo, MD
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
+61 (0)3 9509 6166
Email
info@emeritusresearch.com
First Name & Middle Initial & Last Name & Degree
Stephen Hall, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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A First-in-Human Study of XSTEM-OA in Patients With Knee Osteoarthritis
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