None listed
Conditions
Brief summary
Protocol MSC-OAK-002 is a prospective, observational study that runs concurrently with Protocol MSC-OAK-001 (ANZCTR No. ACTRN12617001095358) Up to 40 subjects with a documented diagnosis of osteoarthritis of the knee, confirmed by X-ray and MRI during Screening, and who have met the eligibility criteria for Protocol MSC-OAK-001 will be offered the opportunity to enrol in this observational study. Following provision of written informed consent and confirmation of eligibility, eligible subjects will commence both protocols on the same day. Subjects enrolled in Protocol MSC-OAK-001 will be on-study for Months 0-3. Subjects enrolled in Protocol MSC-OAK-002 will be on-study for Months 0-12. All potential subjects will be required to provide written informed consent prior enrolment. The study is expected to confirm the safety of donor stem cell treatment in osteoarthritis and also the confirm the most effective treatment dose for pain, functional and structural benefit.
Interventions
This observational trial runs in parallel to the interventional trial MSC-OAK-001 (ACTRN12617001095358). It is designed to assess the efficacy and longer-term safety of investigational product MAG200. Mag200 is a preparation of allogeneic human adipose-derived mesenchymal stem cells (MSCs) in sterile, clinical grade injectable isotonic solution. Up to 40 subjects with a documented diagnosis of osteoarthritis of the knee, confirmed by X-ray and MRI during Screening, and who have met the eligibi
This observational trial runs in parallel to the interventional trial MSC-OAK-001 (ACTRN12617001095358). It is designed to assess the efficacy and longer-term safety of investigational product MAG200. Mag200 is a preparation of allogeneic human adipose-derived mesenchymal stem cells (MSCs) in sterile, clinical grade injectable isotonic solution. Up to 40 subjects with a documented diagnosis of osteoarthritis of the knee, confirmed by X-ray and MRI during Screening, and who have met the eligibility criteria for the parallel interventional trial MSC-OAK-001 will be offered the opportunity to enrol in this observational study. Following provision of written informed consent and confirmation of eligibility, eligible subjects will commence both protocols on the same day. Subjects enrolled in Protocol MSC-OAK-001 will be on-study for Months 0-3. Subjects enrolled in Protocol MSC-OAK-002 will be on-study for Months 0-12. Participants will complete questionnaire based follow-up at 0, 1, 3, 6, 9 and 12 months. Participants will undergo radiological follow-up including Xray and MRI at 12 months. Questionnaires will be completed using online software and independently by the participants. Questionnaires are expected to take up to 20minutes. Radiological imaging at 12 months is expected to take up to 1hour. Participants in this trial will be the same participants enrolled in the interventional trial ACTRN12617001095358.
Sponsors
Magellan Biologicals Pty Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
i) Body mass index BMI must be 'greater than or equal' to 19.0 kg/m2 and 'less than or equal to' 35.0 kg/m2; ii) A documented diagnosis of osteoarthritis (Grade 2 or Grade 3) of the study knee iii) Participants enrolled in the interventional MAG200 study (ACTRN12617001095358)
Exclusion criteria
i) MRI-confirmed displaced meniscal tear, ligament deficiency or generalised Grade 4 chondral loss in the study knee. ii) History of or suspected infective or inflammatory joint disorders. iii) Joint surgery within 3 years prior to study start. iv) Females who are pregnant or planning a pregnancy during the following 12 months. v) Any contraindication to intra-articular injection. vi) Any contraindication to an X-ray or MRI of the study knee.
Outcome results
None listed