None listed
Conditions
Brief summary
Osteoarthritis is a major cause of pain and disability worldwide. Recent research and clinical evidence indicates that Human adipose-derived stem cells are safe for use in Humans. Researchers suggest that the treatment may alter the operation of the immune system to ameliorate degenerative activity. In a conducive environment supported by a combination of growth factors and certain other peptides, stem cells can also be stimulated to differentiate into a range of different cell types facilitating tissue regeneration. In addition, clinical practice using adipose tissue implants indicates that site stability and health is improved with less processed, tissue fractions. In the regulation of therapeutic goods, controversy has arisen concerning the lack of regulation on treatments that involve a high degree of cellular manipulation. The Lipogems product is extracted from the patient’s adipose tissue using a minimal and subtle, physical process without need for enzymatic digestion or cell culturing. This trial is investigating to what extent moderate to severe Osteoarthritis of the knee is modified by an injection of an adipose tissue fraction (Lipogems) obtained from the participants own fat tissue and two different blood extracts : (1) Platelet-Rich-Plasma which contains growth factors released from platelets and endogenous fibrin scaffold which is used to stimulate the natural healing cascade and tissue regeneration directly at the site of treatment; (2) Orthokine, a conditioned blood serum rich in the anti-inflammatory cytokines particularly IL-1Ra which is thought to alter the progression of OA by neutralizing pro-inflammatory cytokines. These treatments are applied in combination with proprietary peptides which are derived from those that are naturally present throughout the body and are critical to cellular processes particularly growth and regeneration. Age and disease conditions can reduce the levels and effectiveness of these peptides which normally promote healing.
Interventions
For the treatment of moderate to severe knee osteoarthritis, this study aims to compare the efficacy of treatment combinations. If eligible, all participant treatment groups are prescribed proprietary peptides; dosage – Commencing 3 weeks prior to liposuction procedure, 3 self-injections of up to 0.2 ml, 5 days/week and continuing for 5 to 10 weeks after procedure (i.e. total duration = 8 to 13 weeks). The peptides are derived from those that are present naturally throughout the body and are cri
For the treatment of moderate to severe knee osteoarthritis, this study aims to compare the efficacy of treatment combinations. If eligible, all participant treatment groups are prescribed proprietary peptides; dosage – Commencing 3 weeks prior to liposuction procedure, 3 self-injections of up to 0.2 ml, 5 days/week and continuing for 5 to 10 weeks after procedure (i.e. total duration = 8 to 13 weeks). The peptides are derived from those that are present naturally throughout the body and are critical to cellular processes particularly growth and regeneration. The ongoing maintenance dose of the peptides via injection is necessary due to their short half-life and most effective circulation and absorption. Participants are randomly divided into three treatment groups receiving either (Group 1) A novel commercial product, Lipogems which uses extracts from the participant’s own adipose tissue (Lipogems are produced by a gradual size reduction of the adipose clusters immersed in saline solution within a single use, sealed, sterile device also eliminating oily and hematic residues); (Group 2) Lipogems and Platelet-Rich-Plasma (PRP is extracted from the patient’s blood via two steps of centrifugation and coagulation. PRP contains growth factors released from platelets and endogenous fibrin scaffold); (Group 3) Lipogems and Orthokine (produced by incubation of blood within a sealed device for 9 hours which induces increased amounts of the protective IL-1RA proteins. Serum ready for injection is subsequently extracted via centrifugation). The clinical procedure (Day 1) uses the Lipogems technique which involves a mini-Liposuction procedure using local anaesthesia and syringe collection from the waist region to collect the adipose tissue specimen (30 gm) for subsequent processing to extract the adipose tissue fraction. Lipogems (15 gm) are injected directly into the joint guided by ultrasound. For Group (3), whole blood (10 ml) is extracted followed by preparation of Orthokine. The duration of the liposuction procedure including extraction, processing and injection is ~ 7 hours. The liposuction procedure occurs only once. Following the procedure, standard supportive measures including antimicrobial prophylaxis are followed as per clinic protocols. On Day 8, whole blood (10 ml) is extracted followed by preparation of PRP for Group (2). On the same day, groups (2) and (3) receive either PRP (10 ml) or Orthokine (10 ml) which are injected directly into the joint (30 min). Any adverse events are monitored at procedures and as reported throughout the trial. Participants are responsible for monitoring adherence to the peptide treatments in a personal log or calendar. Condition specific validated questionnaires are applied at subsequent interviews at 3, 6, and 12 months via telephone. Data will be compared with previous medical history and baseline measurements taken before procedure.
Sponsors
Mastercell Stem Cell Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients who give written consent to participate in the study. Radiological diagnosis of knee osteoarthritis with Kellgren-Lawrence grades 3 - 4 (Patients will need to have imaging findings (radiography or magnetic resonance imaging) that show degenerative changes). Concurrent disease medically stable
Exclusion criteria
inability to give informed consent Known allergies/ hypersensitivities to local anaesthetics or antibiotics Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results Females who are pregnant (detected by urinary hCG in fertile women) or lactation or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study. Anti-coagulant use (as below) that cannot be stopped or bleeding disorders (no use of Warfarin, Aspirin, Vitamin E, fish oil or anti-inflammatory medications 10 days before treatment) Active or chronic infectious disease including infection with HIV1-2 or chronic Hepatitis B or Hepatitis C. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status Immunosuppressed History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. Morbid Obesity Any surgical implant in the knee (plates, pins, rods, screws, prosthesis). Restricted to a wheel chair due to any other condition apart from Osteoarthritis.
Outcome results
None listed