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Trial registered on ANZCTR


Registration number
ACTRN12615000769583
Ethics application status
Not yet submitted
Date submitted
30/06/2015
Date registered
24/07/2015
Date last updated
22/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 287020 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 295487 0
Condition category
Condition code
Musculoskeletal 295742 295742 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292228 0
Treatment: Other
Comparator / control treatment
Lipogems and peptides
Control group
Active

Outcomes
Primary outcome [1] 295459 0
Knee injury and Osteoarthritis Outcome Score (KOOS) compared to baseline score.
Timepoint [1] 295459 0
Post-procedure: 3 months, 6 months, 12 months
Primary outcome [2] 295460 0
Assessment of Quality of Life (AQoL) compared to baseline score.
Timepoint [2] 295460 0
Post-procedure: 3 months, 6 months, 12 months
Primary outcome [3] 295461 0
pain intensity numeric rating scale (NRS) compared to baseline score.
Timepoint [3] 295461 0
Post-procedure: 3 months, 6 months, 12 months
Secondary outcome [1] 315612 0
X-ray analysis knee joint structure compared to baseline.
Timepoint [1] 315612 0
6 months
Secondary outcome [2] 315613 0
Changes in Analgesic and Anti-inflammatory Use as reported by participants at data collection points compared to baseline medication.
Timepoint [2] 315613 0
Post-procedure: 3 months, 6 months, 12 months
Secondary outcome [3] 315797 0
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).
Timepoint [3] 315797 0
day of Lipogem injection, and 1 week follow-up visit and participants reports throughout 12 month trial.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2016
Actual
Date of last participant enrolment
Anticipated
16/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291574 0
Commercial sector/Industry
Name [1] 291574 0
Mastercell Stem Cell Centre
Country [1] 291574 0
Australia
Funding source category [2] 291575 0
Commercial sector/Industry
Name [2] 291575 0
Australian Custom Pharmaceuticals Pty Ltd
Country [2] 291575 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mastercell Stem Cell Centre
Address
Niecon Plaza, 47 / 19 Victoria Ave.,
Broadbeach, QLD 4218
Australia
Country
Australia
Secondary sponsor category [1] 290248 0
Other
Name [1] 290248 0
Adult Stem Cell Foundation
Address [1] 290248 0
PO BOX 8468 GCMC
Bundall, QLD 4217
Australia
Country [1] 290248 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293112 0
Ethics committee address [1] 293112 0
Ethics committee country [1] 293112 0
Australia
Date submitted for ethics approval [1] 293112 0
14/03/2016
Approval date [1] 293112 0
Ethics approval number [1] 293112 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Participants are required to contribute to trial costs and no remuneration for personal expenses is available. Treatment requires two visits to study centre (Broadbeach) on days1 and 8.

Contacts
Principal investigator
Name 58514 0
Dr Soraya Felix
Address 58514 0
Mastercell Stem Cell Centre
47 / 19 Victoria Ave.,
Broadbeach QLD 4218
Country 58514 0
Australia
Phone 58514 0
+61 7 5526 7001
Fax 58514 0
Email 58514 0
[email protected]
Contact person for public queries
Name 58515 0
Mark Edwards
Address 58515 0
c/-Mastercell Stem Cell Centre
47 / 19 Victoria Ave.,
Broadbeach QLD 4218
Country 58515 0
Australia
Phone 58515 0
+61 7 5526 7001
Fax 58515 0
Email 58515 0
[email protected]
Contact person for scientific queries
Name 58516 0
Mark Edwards
Address 58516 0
c/-Mastercell Stem Cell Centre
47 / 19 Victoria Ave.,
Broadbeach QLD 4218
Country 58516 0
Australia
Phone 58516 0
+61 7 5526 7001
Fax 58516 0
Email 58516 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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