current controversies of stem cell therapies conf preso's... · 2017-02-13 · current...
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Current Controversies of Stem Cell
Therapies
Professor Minghao Zheng, MD, PhD, FRCPath, FRCPA
Medical School
Associate Dean, Faculty of Health and Medical Sciences,
The University of Western Australia, Perth, WA, 6009
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Declaration of Interest
I declare that in the past three years I have:
• held shares in Orthocell Ltd;
• received institutional support from NHMRC, ARC
Signed: minghao zheng
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• What are the controversies surrounding
stem cell therapies?
• How do we define the boundaries of
practice?
• Is there a place for stem cell therapy in
Orthopaedics
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Life starts with blastocyte stem cells
Inner cluster mass (ICM) of blastocytes
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Stem cell therapy is not new
• First cellular therapy in
1959
• Dr Georges Mathé
• Conducted first bone
marrow cell therapy on five
Yugoslavian nuclear
workers whose own
marrow had been damaged
by irradiation
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E Donnall Thomas
• Development of bone marrow
transplantation as a treatment
for leukaemia;
• In 1990, he shared the Nobel
Prize in Physiology or
Medicine with Joseph E.
Murray for the development of
cell and organ transplantation.
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Induced Pluripotent Stem Cells (iPSC)
Turning Back the Cellular Clock: A
Farewell to Embryonic Stem Cells?
Shinya Yamanaka 2012
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Stem cells – the public perception
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Stem cells are not a miracle
There is “emerging” evidence it may work
to repair corneas to prevent the most
common causes of blindness. It is looking
promising in cerebral palsy, to treat lung
damage in premature babies and
osteoarthritis among many others.
But for all the other ailments, from anti-
ageing to autism, spinal cord injury to
Alzheimer’s disease, the consensus from
Australia’s leading experts is; “there is not
a shred of evidence it works”.
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Stem cells are required more
research, We don’t want to
see…
• Lack of sufficient pre-clinical evaluation;
• Exploitation of regulatory loopholes;
• Lack of research and clinical evidence;
• Overpromise;
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Shapiro et al, A Prospective, Single-Blind, Placebo-
Controlled Trial of Bone Marrow Aspirate Concentrate for
Knee Osteoarthritis. Am J Sports Med. 2016 Aug 26
Patients experienced a similar relief of pain
in both BMAC- and saline-treated arthritic
knees !
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Common adverse events of stem cells therapies
Same day procedure is
relatively safe (SD);
Fat oil from adipose tissue
cause pain (AD);
Cultured MSCs promote
disease progression (CE).
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Australia Research Council launches
roadmap for Australian stem cell science
Position statement 21 March 2016
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Recommendations
• Clinicians to establish a boundary of clinical
practice;
• Improve community engagement and
awareness of stem cell research and
therapy;
• Improve patient access to clinical trials;
• Facilitate cross disciplinary collaboration
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Liposuction stem cell therapy Stem cell clinics
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• What are the controversies surrounding
stem cell therapies?
• How do we define the boundaries of
practice?
• Is there a place for stem cell therapy in
Orthopaedics
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• MACI - Autologous chondrocyte
implantation for cartilage
injuries;
• ATI - Autologous tendon cell
injection for tendinopathy and
tear.
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Am J Sport Med 2010 38:1259
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Matrix induced ACI (MACI)Cell-scaffold construct
GMP Lab
30 minutes
surgery;
small incision
or
arthroscope
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Zheng et al 2006
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SUMMIT Trial
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• MACI - Autologous chondrocyte
implantation for cartilage
injuries;
• ATI - Autologous tendon cell
injection for tendinopathy and
tear.
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Substitution of tendon cell by
injection to central tear site
improve tendon healing in
tendinopathy.
Research Evidence of ATI
Chen et al 2007; 2011; Wu et al 2011; Zheng et al Science (supplementary) 2012
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Feridex cell tracking within the tendon
J Chen, M.B.Ph.D.et al TISSUE ENGINEERING: Part A 17:15, 2011 Cover page
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BMJ 2013
AJSM 2014
AJSM2013
Clinical Evidence: level III/IV
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Indication Expansion = 376 cases
Gluteal Tendon =17
Patellar Tendon = 27
Hamstring Tendon = 9Rotator Cuff =36
Achilles Tendon =17
Tennis elbow = 52
Adductor and Biceps = 3
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• Post-market surveillance indicating that
70.7% of patients were satisfied with the
outcome of their Ortho-ATI® treatment
(including both the resolution of symptoms
and ability to resume daily activities).
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Level II Clinical Evidence: Outcome of ATI
RCT study in Holland
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Level II Clinical evidence
Comparison of ATI with surgery in patients
with chronic resistant lateral epicondylitis
(ACTRN12616000458437p),
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Rest
Physio-therapy
Injection
Cell
Surgery
Treatment principle and algorithm of tendinopathy
Pathogenesis Treatment principle
Overuse Avoid re-injury
Angiofibroblastichyperplasia
Mechanical induction ofintrinsic repair
Degenerative change of tendon cell & matrix
Control of pain
Matrix breakdown& Fatigue healing
Substitution of tendon progenitor cells for
tendon repair
Structural changes with mechanical failure
Correction of biomechanics & decompression
Bhabra et al JOSM 2016
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Take home messages
- Clinicians need to define their boundary of
practice for stem cell therapy;
- Any stem cells injection into joint have shown
not working;
- Autologous chondrocyte implantation works for
localised cartilage injury and is an FDA
approval cellular product;
- Autologous Tenocyte Injection is working but
need higher level of clinical evidence (level II
and above).
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THANK YOU