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Stem Cell Research and Tissue Engineering
Sheila Mac Neil Professor Of Tissue Engineering and founder Director of Celltran Ltd
Ethical & legal challenges to Stem Cell research
Sheila MacNeil
University of Sheffield
Skin Forum Sheffield June 2006
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Contents
• Tissue engineering research using adult cells
Skin-burns patients
Skin-chronic ulcers
Oral mucosa-scarring of the urethra
Melanocytes-vitiligo
Corneal epithelial cells-corneal diseases
• Ethical Regulatory and Economic issues
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TMDo we have stem cells in our cultures?
• Adult epithelial cells (skin, oral mucosa and cornea) cultured
in the laboratory contains cells with colony forming ability
which give rapid expansion
• Patients who received cultured skin in the 1980’s still doing
well-no loss of skin
• Concensus view is that culture protocols maintain a population
of cells with “stem like” properties but that without gene
manipulation these are destined to give rise to only one tissue
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10 year audit of use of CEA (Hernon et al 2006)
1 4 5 6 8 9 11 12 14 15 18 21 22 24 25 27 32 35 37 38 2 3 7 10 13 16 17 19 20 23 26 28 29 30 31 33 34 36 390
50
100
0
18
0
29
0
0
33
39
25
24
0
9
16
12
6
Patient number
Did not receive donor skin%
To
tal b
od
y su
rfa
ce a
rea
Patient number
Received donor skin
9
35
20 0
15
40
2319
54
20
0
0
30
11
0
0
12
18
14 0
120
0
0
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There had to be a simpler way to get cells to patients…
• Professor Rob Short-Surface Engineer
• Professor Sheila MacNeil-Tissue Engineer
“Lets make a post-it note for delivering skin cells to
patients” 1997
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• University of Sheffield spin-out company
• Formed 2000
• 16 staff
• MHRA approved cleanrooms in 2003
• Launched Myskin in 2004
• Merged with Xcellentis in 2006
• Raised 5 Million in funding
• Full details of development and proof of concept clinical studies with myskin Full details of development and proof of concept clinical studies with myskin
available on www.celltran.co.ukavailable on www.celltran.co.uk
Celltran Ltd
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• Autologous keratinocytes
• Proprietary materials
technology
• Chronic wounds, burns
• DFU/VLU trials
• Case studies
• Revenues since April 2004
Myskin™
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Patient Information
Thin shave biopsy taken and delivered to CellTran
Cryogenic cell storage
myskin
surface
Cell expansion at CellTran laboratory
Repeat myskin delivery as required
Wound healing
Wound bed preparation – debride and optimise*
Myskin couriered to patient
Week 0 Week 1 Weeks 2-6-2 days
myskin process
© CellTran Limited
TMUse of Myskin for failed skin grafts Patient 5 Male, 80 years old
4 weeks non-healing Right leg before applications
After 12 applications – 78% healed, suitable for grafting
2 months post treatment
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What types of patients can benefit ?
• Acute burns-where it provides valuable adjunct
to SSG and donor skin
• Chronic wounds-BUT-the earlier it is used the
better the outcome and the fewer applications
will be needed
• Chronic wounds of long standing may need
pretreatment to improve the wound bed prior to
application
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Development a carrier surface for surgical treatment of vitiligo
Cells on carrier surfaceBiopsy
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TMTransfer of melanocytes and keratinocytes from carrier to in vitro human wound bed model
0
50
100
1stQtr
3rdQtr
East
West
North
H&
Melanoc
MTT of carrier dressing
MTT of fresh skin
S100
Melanocytes
Mel-5
Melanocytes
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Developing a coated contact lens as a carrier for cultured corneal cells for corneal diseases
Contact lens
Agar
Stroma
Sclera
Contact lens seeded with limbal epithelial cells
Organ culture
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TMTissue engineered skin and oral mucosa for reconstructive surgery
• Tissue engineered skin for release of
contractures due to earlier burns injuries
• Tissue engineered oral mucosa for
replacing chronically scarred urethral
tissue
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TMEthical, Regulatory and Economic issues
Ethical issues
• Why do this? -Because existing clinical
treatments not adequate for job
• What is the risk versus the benefit for patients?
• What can go wrong? How likely is it?
• Obtaining Ethical Committee consent
• Making sure patients are fully informed and
properly consented
© CellTran Limited
TMEthical, Regulatory and Economic issues
Ethical issues-in practice
• Patients very willing to use own tissues (small
biopsy) for burns, chronic wounds and
reconstructive surgery problems
• Ethical Committees open to research which
seeks to tackle such problems
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Regulatory issues
• Regulatory bodies react to established procedures
• Strong drive to classify work according to previous
medical technologies-is it a device? –is it a medicine?
• Tissue Engineering doesn’t fit either of above well
and is being driven towards Medicinal Products
• Running trials on autologous cell treatments not like
drug development……not a great fit…
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Regulatory issues
• UK Regulatory bodies can be approached-you
can get meetings –decisions are harder
• Real need to work closely with MHRA and HTA to
inform them of how fields are progressing
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Economic issues
• Products currently represent a small proportion of treatment cost
• New technology will increase cost of product but reduce total cost to provider
• Health economics are driving cure over treatment
Co
st o
f h
eali
ng
in
dex
Traditional ActiveAdvanced
Nursing time
Products
Other costs
Over 4 years
Source: Husing et al, 2003. The Future of Wound Care, MX (Market Analysis II) LEK Consulting, Feb 2006
UK cost per ulcer per
yearSource: Swedish Institute for Health Economics, 2000
£ 11,500
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Our philosophy of product development based on adult
autologous cells is that these should be
• Clinically effective
• Low risk for the patient
• Developed by working with clinicians and patients
• Convenient to use –streamlined delivery
We have developed a range of products and indications in
the ‘active’ sector using autologous cells
Summary
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