The Cell Therapy Program

• Read more about the on-line guide for clinical studies in cell therapy, now maintained by KTA, KArolinska Trial Alliance.

Cell therapy is the future treatment of many diseases – with the potential to revolutionize health care. The challenge now is to improve the efficiency and quality of the development process for these new treatment concepts, says Tomas Borgegård from the Center for Innovation, who leads the Cell Therapy program.

Cell therapy is the use of cells to treat diseases and has its origins in blood transfusion and in vitro fertilization, as well as bone marrow and organ transplantation. The expectation is that cell therapy will be able to treat a wide range of previously incurable diseases, such as many cancers, Parkinson's disease and diabetes.

The benefit to society is significant when large groups of patients are able to gain access to cell therapy and thereby potentially cure and avoid chronic conditions requiring lifelong treatment.

New collaboration will take the therapies to patients

Establishing new cell therapy treatments is a complex task, which needs the involvement of many specific competences from different areas like academia, regulatory, industry, production/manufacturing, investors, and healthcare providers. In this program academia, industry and healthcare aspire to find new, innovative solutions to increase the chances of bringing cell therapies all the way to the patient.

New partnerships will take the therapies to patients

 Establishing new cell therapy treatments is a complex task, which needs the involvement of many specific competences from different areas like academia, regulatory, industry, production/manufacturing, investors, and healthcare providers. In this program academia, industry and healthcare aspire to find new, innovative solutions to increase the chances of bringing cell therapies all the way to the patient.

Hospitals and academia paving the way

Only a few cell therapy medicinal products currently have market approval. The major pharmaceutical companies that traditionally pay for clinical development of new drugs have not yet invested to any great extent in this new field. Instead, hospitals, universities and small biotech companies in particular are driving the development of new cell therapies.

In many ways, development of cell therapies marks a paradigm shift for health care since the hospital has taken over sponsorship of the clinical studies that drug companies historically assumed. In this new model, the hospital has the primary responsibility for managing and coordinating studies, and for complying with applicable regulatory requirements, laws and directives with regard to efficacy, safety and quality.

Development of new cell therapies therefore places high demands on the hospital organization, as well as on employee expertise in drug development. To further complicate the situation, the current regulatory framework is not fully adapted to cell therapies; for example, ambiguity exists as to whether or not cells should be classified as drugs.

Unlike conventional drugs, cell therapy is largely customized to the individual, which means that handling of cells from patients and donors, as well as production of cell therapy medicinal products largely takes place within the confines of the hospital in units that specialize in handling cells.