ACTRN12615000769583
Not yet recruiting
Phase 1
A parallel, interventional study to evaluate the efficacy of current products utilizing participant’s adipose tissue (Lipogems technique) and participant’s blood extracts (Orthokine or Platelet-Rich-Plasma) in combination with injections of human peptide derivatives for the treatment of moderate to severe knee osteoarthritis.
Mastercell Stem Cell Centre0 sites45 target enrollmentJuly 24, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Mastercell Stem Cell Centre
- Enrollment
- 45
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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