A study comparing the efficacy of current products utilizing participant’s adipose tissue (Lipogems technique), and blood extracts (Orthokine or Platelet-Rich-Plasma (PRP)) in combination with peptide injections for the treatment of moderate to severe knee osteoarthritis.

Phase 1

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12615000769583
• Lead Sponsor: Mastercell Stem Cell Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline score.[Post-procedure: 3 months, 6 months, 12 months];Assessment of Quality of Life (AQoL) compared to baseline score.[Post-procedure: 3 months, 6 months, 12 months];pain intensity numeric rating scale (NRS) compared to baseline score.[Post-procedure: 3 months, 6 months, 12 months]

Secondary Outcome Measures

Name	Time	Method
X-ray analysis knee joint structure compared to baseline.[6 months];Changes in Analgesic and Anti-inflammatory Use as reported by participants at data collection points compared to baseline medication.[Post-procedure: 3 months, 6 months, 12 months];The safety of protocol will be evaluated by assessment of the number, time-frame of occurrence and severity of Adverse Events (Adverse Events will be graded by the Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Adverse events monitoring will consist of measurement of signs at injection site such as inflammation, infection, and stiffness of the joint and vital signs (temperature, heart rate, blood pressure, respiration).[day of Lipogem injection, and 1 week follow-up visit and participants reports throughout 12 month trial.]