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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. Stem Cell Research and Tissue Engineering. Contents.

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Stem cell research and tissue engineering

Sheila Mac NeilProfessor Of Tissue Engineering and founder Director of Celltran LtdEthical & legal challenges to Stem Cell research

Sheila MacNeil

University of Sheffield

Skin Forum Sheffield June 2006

Stem Cell Research and Tissue Engineering


Contents
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



Do we have stem cells in our cultures
Do 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



10 year audit of use of cea hernon et al 2006
10 year audit of use of CEA in”(Hernon et al 2006)


There had to be a simpler way to get cells to patients
There had to be a simpler way to get cells to patients… in”

  • Professor Rob Short-Surface Engineer

  • Professor Sheila MacNeil-Tissue Engineer

    “Lets make a post-it note for delivering skin cells to patients” 1997


Celltran ltd
Celltran Ltd in”

  • 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 available on www.celltran.co.uk


Myskin
Myskin™ in”

  • Autologous keratinocytes

  • Proprietary materials technology

  • Chronic wounds, burns

  • DFU/VLU trials

  • Case studies

  • Revenues since April 2004


Myskin process

Wound bed preparation – debride and optimise* in”

myskin

surface

-2 days

Week 0

Week 1

Weeks 2-6

Cell expansion at CellTran laboratory

Thin shave biopsy taken and delivered to CellTran

Myskin couriered to patient

Repeat myskin delivery as required

Wound healing

Patient Information

Cryogenic cell storage

myskin process




Use of Myskin for failed skin grafts in”

Patient 5Male, 80 years old

Right leg before applications

4 weeks non-healing

After 12 applications – 78% healed, suitable for grafting

2 months post treatment




What types of patients can benefit
What types of patients can benefit ? in”

  • 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






D evelopment a carrier surface for surgical treatment of vitiligo
D in”evelopment a carrier surface for surgical treatment of vitiligo

Cells on carrier surface

Biopsy


Transfer of melanocytes and keratinocytes from carrier to in vitro human wound bed model

MTT of carrier dressing in”

S100

Mel-5

Melanocytes

MTT of fresh skin

Melanocytes

Transfer of melanocytes and keratinocytes from carrier to in vitro human wound bed model


Developing a coated contact lens as a carrier for cultured corneal cells for corneal diseases

Contact lens seeded with limbal epithelial cells in”

Stroma

Agar

Sclera

Organ culture

Contact lens

Developing a coated contact lens as a carrier for cultured corneal cells for corneal diseases


Tissue engineered skin and oral mucosa for reconstructive surgery
Tissue 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





Ethical regulatory and economic issues
Ethical, Regulatory and Economic issues surgery

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


Ethical regulatory and economic issues1
Ethical, Regulatory and Economic issues surgery

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


Regulatory issues
Regulatory issues surgery

  • 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…


Regulatory issues1
Regulatory issues surgery

  • 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


Economic issues
Economic issues surgery

  • 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

Cost of healing index

Nursing time

Products

Other costs

Source: Husing et al, 2003. The Future of Wound Care, MX (Market Analysis II) LEK Consulting, Feb 2006

Traditional

Advanced

Active

Over 4 years


Summary
Summary surgery

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


Acknowledgements
Acknowledgements surgery

Grateful thanks to all those patients and clinicians who have worked with us to develop tissue engineered skin products for the treatment of burns and chronic wounds.


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