SDP2 Stem Cells

SDP2: Challenges and opportunities for stem cell based medical products in Sweden

Lead: Uppsala Universitet – Institutionen för folkhälso- och vårdvetenskap, Centrum för forskningsetik & bioetik.

Involved partners: AstraZeneca AB, Göteborgs Universitet, Karolinska Institutet, Karolinska Universitetssjukhuset, Lunds Universitet, Region Skåne, Takara Bio Europe AB.

SDP2 aims to pave the way for ATMPs manufactured from pluripotent stem cells (human embryonic stem cells or induced pluripotent stem cells). The group provides a network for issues around legal and ethical frameworks. A value survey will provide information on how the public values development of medicinal products from embryonic stem cells for different medical conditions. The goal is to write a “handbook” on developing pluripotent stem cell lines for clinical use.

Examples of tasks and actions:

  • Identification of needs, hurdles and opportunities.
  • Work shop gathering researchers, manufacturers, companies and authorities to set a common ground for definitions around pluripotent stem cells and products derived from them.
  • Case studies describing academically and commercially developed stem cell lines.
  • Value survey on embryonic stem cells.

Final report/deliverables;

Slutrapport SDP2 Swelife-ATMP

Presentation Workshop 190903

Bilaga 1 Inbjudan och synopsis ws nr 1 181113

Bilaga 2 Inbjudan och presentation ws nr 2 190903

Bilaga 3 Slutrapport SDP2 Takara Bio 200812

Bilaga 4 Slutrapport SDP2 Anna Falk KI 200812

Bilaga 5 Slutrapport SDP2 kvalitativ

Interview with Project Leader

Hi Mats Hansson!

What is the need your project addresses?

The use of human embryonic stem cells for medical product development carries a great promise for improved therapy provided to patients. At the same time these cells are by most people regarded not as simply ordinary tissue but as origins of human life implying special concern and respect. Progress in the field of stem cell based medicine needs to be anchored and to a reasonable extent consistent with the values of patients, donating couples and the general public. There are also legal challenges that need to be addressed.

What is your approach to meet the need?

Regarding both the ethical and the legal challenges one needs to be proactive. We will identify ethical and legal issues in concrete projects related to research and devlopment in good time before research results are going to be commercialized and products enter the market.  In a coming project we will address pertinent issues in intellectual property law.

Why is this better than what´s currently available? Alt How will this improve Sweden´s capabilities within ATMPs?

With a few exceptions stem cell based research and product development have been flying under the radar of public interest. With this project we will be able to help researchers, companies and funding agencies to be prepared to handle ethical and legal issues that, if not taken seriously, may hamper the development of ATMPs and Swedish innovation in this field, something that would clearly be detrimental for many patients waiting for efficient therapy.

For more information please contact Mats Hansson