Knee Osteoarthristis
Conditions
Keywords
osteoarthritis
Brief summary
The purpose of this study is to confirm whether MAG200 (20M or 100M) will improve pain and function of participants with osteoarthritis of the knee compared with placebo. In addition, the two strengths of MAG200 will be compared. In this study, participants will receive a single injection of placebo or allogeneic ADMSCs (MAG200) administered by IA injection. Participants will be randomised to receive placebo, or MAG200 at a dose of 20 million cells (20M), or MAG200 at a dose of 100 million cells (100M). It is anticipated that the study will run for approximately 48 months.
Interventions
BIOLOGICALallogeneic human adipose-derived mesenchymal stem cells
The Investigational Product MAG200 is a preparation of 5 mL allogeneic human adipose-derived mesenchymal stem cells (MSCs).
OTHERPlacebo
Placebo is commercially available injectable normal saline (0.9% Sodium Chloride in Water for Injection)
Sponsors
Magellan Stem Cells
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants in this study will be randomised to receive placebo, or MAG200 at a dose of 20 million cells (20M), or MAG200 at a dose of 100 million cells (100M).
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females aged ≥ 35 years to ≤ 75 years inclusive. 2. BMI ≥ 19.0 to ≤ 35.0 kg/m2. 3. Documented clinical diagnosis of OA of the study knee. 4. Documented radiological grading of Grade 2 or Grade 3 medial and/or lateral compartment OA of the study knee. 5. Documented radiological grading of OARSI JSN 1-2 of the medial and/or lateral compartment of the study knee. 6. Primary OA treatment of the study knee already attempted within the last 12 months, defined as: 1. Prescribed analgesia/anti-inflammatory medication where appropriate, AND 2. an attempted exercise program prescribed by a physical therapist (e.g., physiotherapist, osteopath) or medical practitioner for at least 8 weeks, AND 3. weight management, where appropriate. 7. Moderate to severe knee specific activity related pain score on the NRS for Pain over the past week. 8. Moderate to severe knee specific functional limitation on KOOS-PS. 9. Less than 5 degrees varus or valgus knee deformity of the study knee relative to neutral alignment.
Exclusion criteria
1. Any of the following relating to the study knee: 1. Radiological evidence of KL Grade 4 OA (involving medial, lateral and/or patellofemoral compartment) or OARSI JSN 3. 2. History of recurrent mechanical instability and / or locking. 3. Joint surgery or significant knee injury within 12 months prior to Day 1. 4. Metal in-situ resulting in metal artefact which impacts/prevents MRI assessment. 5. MRI confirmed: i. Generalised full thickness chondral loss involving tibial and/or femoral weight bearing surfaces ii. Total meniscectomy iii. Complete posterior meniscal root tear iv. Subchondral insufficiency fracture v. Osteonecrosis vi. Malignant bone marrow infiltration vii. Solid tumors viii. Traumatic fracture/bone contusion ix. Knee pathology requiring orthopaedic assessment/intervention (e.g., significant loose body) 2. Other causes of the knee symptoms unrelated to knee OA. 3. Significant and debilitating OA in the non-study knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of MAG200 on osteoarthritis pain and function | 12 months | Co-primary endpoints: * Change from baseline in pain by Knee Injury and Osteoarthritis Outcome Score pain subscale (KOOS Pain): 0-100 scale (0=extreme knee pain, 100=no knee pain) * Change from baseline in function as measured by Knee Injury and Osteoarthritis Outcome Score function in daily living subscale (KOOS-ADL): 0 to 100 scale (0=extreme knee problems, 100=no knee problems) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effect of MAG200 on osteoarthritis pain | 1, 3, 6, 9, and 12 months | Change from baseline in activity related pain assessed using an 11-point (0 to 10) Numeric Rating Scale (NRS) (0=no pain, 10=extreme pain) |
| To assess the response rate of MAG200 | 1, 3, 6, 9, and 12 months | Response according to OMERACT-OARSI (Outcome Measures in Rheumatology - Osteoarthritis Research Society International) Responder Analysis. OMERACT-OARSI response is defined as either 1) improvement in pain or physical function ≥ 50% and an absolute change ≥ 20 points on a 0-100 scale; or 2) improvement of ≥ 20% and with an absolute change ≥ 10 points on a 0 to 100 scale in at least two of the following three categories: pain, physical function, and patient's global assessment of osteoarthritis activity. |
| To assess the effect of MAG200 on radiological progression | 12 months | Change from baseline in articular cartilage thickness assessed by quantitative MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event reporting | Baseline to 12 months | Incidence of treatment emergent adverse events |
Contacts
Primary ContactJulien Freitag, MBBS, BMedSci
Outcome results
None listed