None listed
Conditions
Brief summary
The primary objective of this study is to determine the safety and tolerability of autologous stromal vascular fraction (SVF) compared to placebo in patients with osteoarthritis of the knee. Secondary objectives are intended to measure differences between placebo and SVF based therapies including improved pain control, improvement of WOMAC, weight bearing x-rays, improvement in the AQoL (Australian Quality of Life) instrument, reduction in rescue medication consumption and MRI to assess disease modifying activity.
Interventions
This study will look to assess the safety and response of knee osteoarthritis to different dosing and injection protocols of stromal vascular fraction (SVF), platelet rich plasma (PRP) and Hyaluronic acid (HA). Sixty four participants will be enrolled in the study and randomly separated into 4 study groups.
Group 1: Placebo Day 0 (Intravenous (IV) + Intra-articular (IA)) and placebo IA at Days 7, 14 and 21
Group 2: SVF + PRP (IA) + placebo (IV) at Day 0, and placebo IA at Days (7, 14 and 21)
This study will look to assess the safety and response of knee osteoarthritis to different dosing and injection protocols of stromal vascular fraction (SVF), platelet rich plasma (PRP) and Hyaluronic acid (HA). Sixty four participants will be enrolled in the study and randomly separated into 4 study groups. Group 1: Placebo Day 0 (Intravenous (IV) + Intra-articular (IA)) and placebo IA at Days 7, 14 and 21 Group 2: SVF + PRP (IA) + placebo (IV) at Day 0, and placebo IA at Days (7, 14 and 21) Group 3: SVF (IV + IA) + PRP (IA) at Day 0, and placebo (IA Days 7, 14 and 21) Group 4: SVF (IV +IA) + PRP/HA (IA) at Day 0, and PRP (IA) at Days 7, 14 and 21 Autologous non-expanded SVF from adipose (fat) will be used due to the ease of harvest (liposuction) and safety. On average 100 million cells are injected into the joint and 1.5 million/kg intravenously. Adipose tissue is removed by lipo-aspiration (about 60 minutes). The fat is processed on-site to isolate the cells (this process takes up to 40 mins). The suspension of stem cells is injected into the knee joint under ultrasound guidance, and intravenously (about 60 minutes). The PRP (3ml) process involves separating out platelets with plasma from a small amount of blood taken, and takes about 15 mins. Hyaluronic acid is approved for use in Australia and is routinely used in the treatment of knee osteoarthritis, 1 mL will be injected into the joint. The harvesting of adipose and the PRP processing will be performed on the same day as the injection of SVF and PRP, respectively.
Sponsors
Dr David Mathers
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. X-ray reporting grade 2 or more osteoarthritis of the knee Kellgren and Lawrence scale 2. WOMAC score greater than 50. 3. Greater than 6 months knee pain with the index side (left or right) predominately on one side. 4. Pain worse with activity. 5. An improvement in pain score (>10%) as measured by Numerical Rating scale (NRS, 0-10) within 2 weeks after PRP injection. 6. Sufficient fat present for liposuction 7. Adequate blood chemistry and hematopoietic, renal, cardiovascular, respiratory, immunological function
Exclusion criteria
1. Participants who have received investigational agents within 4 weeks (or 5 half-lives) of treatment. 2. Subjects with significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of the study. 3. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders. Participants who have had active neoplastic disease (cancer) in the previous 3 years. 4. Presence of active infection (except for colds or minor URTI). History of human immunodeficiency virus or acquired immune deficiency syndrome. Significant peripheral vascular disease. 5. Participants who are pregnant or lactating. Female participants who have positive serum beta HCG pregnancy test taken within 7 days before treatment. 6. Fertile participants who are not using effective contraception (e.g., oral contraceptives, intrauterine devices, double barrier methods such as condoms and diaphragms, abstinence or equivalent measures). 7. Previous treatment with SVF. 8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to: a) Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis b) Procedures planned during the study period which could interfere with pain assessment (e.g. surgery). c) Other causes of chronic pain (e.g. low back pain, hip pain). d) Intrarticular/periarticular therapies in the past 6 weeks. e) Patients taking glucosamine, unless they have been on a stable dose for at least 2 months. Similarly NSAIDs and COX-2 inhibitor dosing must have been stable for at least a month. f) Major surgery within the past 3 months. g) Corticosteroid injection at treatment site within 1 month. e) Systemic use of corticosteroids within 2 weeks. f) Consistent use of NSAIDs within 48 hours of procedure. g) Aspirin (except low dose for cardioprotection), Vitamin E, Fish Oil or anti-inflammatories for one week prior. h) Knee instability. i) A varus/valgus deformity of more than 10 degrees, a deformity requiring osteotomy or complex surgery. J) Gout or pseudogout k) History of more than one surgical procedure to the knee in question or previous lower extremity amputation l) Co-existents of inflammatory arthritis (e.g. rheumatoid, psoriatic and ankylosing spondylitis arthritis) 9. Obesity defined as BMI > 35 10. Participants unable to tolerate MRI. 11. Inability to understand the study or complete WOMAC/Oxford/AQoL questionnaires. 12. Inability to provide informed consent. 13. Patients that are allergic to avian proteins, feathers or egg products
Outcome results
None listed