Cell- and tissue-based therapies

Monoclonal antibodies for in vivo use Cytokines (e.g. interferons and interleukins) Therapeutic enzymes Thrombolytic agents Hormones Growth factors Additional miscellaneous proteins Blood Blood proteins (e.g. albumin and blood factors) Vaccines Cell- and tissue-based products Gene therapy products Antitoxins, venoms and antivenins Allenergic extracts... 

Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (August 2007) Guidance for FDA Reviewers and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) (April 2008)... 

Perhaps the application for human stem cells with the most potential is the generation of cells and tissues for the cell-based therapies. The demand for donated organs and tissues far outweighs the supply. Stem cells could possibly be directed toward the production of replacement cells and tissues to treat Parkinson s disease, Alzheimer s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis. 

Zimmermann U, Mimietz S, Zimmermann H, et al. Hydrogel-based non-autologous cell and tissue therapy. Biotechniques 2000 Sep 29(3) 564-572, 574, and 576. 

In the conventional applications of photodynamic therapy (PDT), fight-activated chemicals (photosensitizers) are used to destroy fast-growing cells and tissues. The commonly used sensitizers are based upon porphyrin-like molecules, e.g., porphyrins, chlorins, bacteriocholins, and phthalocyanines. These substances collect in... 

Photopolymerizable systems have received a lot of recent attention in biomaterial applications due to the ability to rapidly form a solid polymer (gel) from a liquid precursor solution (monomer or macromer) with spatial and temporal control under physiological conditions. The development of cytocompatible systems has provided the ability to form materials in the presence of proteins, cells, and tissues to allow for minimally invasive biomaterial-based therapies. In particular, photopolymerizable systems have been used extensively as dental restoratives, controlled microenvironments to study cellular behavior and develop tissue substitutes, and to encapsulate growth fartors and cytokines in a polymer matrix for controlled release applications. 

Biotechnology cell and molecular biology transplantation genetic engineering cell and tissue transplantation cloning ceU-based therapies regenerative medicine. 

A further committee. The Committee for Advance Therapies, is to be established under regulation (EC) No. 1394/2007 to deal with issues raised by emerging drug products based on gene therapy, somatic cell therapy and tissue engineering. 

Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP and Hedrick MH (2001). Multilineage cells from human adipose tissue implications for cell based therapies. Tissue Eng 7 211-228. 

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