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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05344157
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : May 31, 2022
Sponsor:
Collaborator:
Xintela AB
Information provided by (Responsible Party):
Xintela AB ( Xindu Pty Ltd )

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: XSTEM-OA Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: XSTEM-OA
Single intra-articular injection of XSTEM-OA
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.




Primary Outcome Measures :
  1. Safety and tolerability: Adverse events (AEs) [ Time Frame: From start of study until 18 months after injection ]
    Incidence, nature and severity of treatment-related AEs assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

  2. 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.

  3. 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.

  4. Safety and tolerability: Physical examinations [ Time Frame: From start of study until 18 months after injection ]
    Changes in physical examination compared to baseline.

  5. 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.


Secondary Outcome Measures :
  1. Preliminary efficacy: Changes in Visual Analogue Scale (VAS) for pain compared to baseline [ Time Frame: From start of study until 18 months after injection ]
  2. 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 ]
  3. 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 ]
  4. Preliminary efficacy: Change in 40 m fast paced walk test compared to baseline [ Time Frame: From start of study until 18 months after injection ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05344157


Contacts
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Contact: Central contact +46 (0)734 122045 clinicaltrials@xintela.se

Locations
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Australia, Victoria
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Contact    +61 (0)3 9509 6166    info@emeritusresearch.com   
Principal Investigator: Stephen Hall, MD, PhD         
Sponsors and Collaborators
Xindu Pty Ltd
Xintela AB
Investigators
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Study Director: Per Norlén, MD, PhD Xintela AB
Principal Investigator: Stephen Hall, Dr Emeritus Research
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Responsible Party: Xindu Pty Ltd
ClinicalTrials.gov Identifier: NCT05344157    
Other Study ID Numbers: XIN-XSTEM-101
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases