Cellular Therapy

Cellular Therapy

Cellular therapy (also called cell therapy) can be defined as an approach that inject or implant cellular materials such as human cells from a donor or animal cells used to cure illness into a patient. Now, as cell therapies promise to cure many types of diseases, there is a large of pressure to require rapid regulatory approval. Since there is no "one size fits all" regulatory approach for different cellular therapies, CD BioSciences is dedicated to providing tailored clinical studies depending on the characteristics of specific product.

Our Services

We will cooperate with our clients in the every stage of clinical trials from early phase through late phase, providing a thorough trial plan, select appropriate subjects and site, and monitor the whole test process.

• We provide case-by-case testing strategy according to the diversity and inherent biological properties of cellular therapy products.
• A specialized clinical operation team with in-depth experience in the management of clinical trials can provide proactive solutions to the operational complexities in cellular therapy, efficiently execute clinical trials.
• We provide a series of safety studies such as thromboembolic safety testing, immunological safety testing and oncological safety testing during clinical trials based on potential product-specific adverse outcomes. To realize safety monitoring and understanding of clinical effect of cellular therapy, the cell tracking techniques based on noninvasive imaging modalities will be employed.
• To further ensure the safety and efficacy of candidate cellular therapy, we conduct long term follow-up to the subjects.

Fig.1 System for delivering individualized, autologous, ex vivo, cellular therapies. (Elverum, Kris, and Maria Whitman, 2019)

• Advanced cold chain logistics and cell storage and growth equipment can meet the specific requirements of cellular therapy.
• The safety teams have rich experience in the monitoring of cellular therapy studies.
• Regulatory experts are familiar with the latest developments and global regulations about the cellular therapy, they have in-depth knowledge of the FDA and EMA processes related to cellular therapy clinical development pathways.

Your product has the potential to become life-changing treatment, our task is to help you bring it to the market in shortest time. CD BioSciences is dedicated to providing comprehensive suite of clinical development services to anticipate challenges, overcome obstacles so that facilitate your cellular therapy development program. If you are interested in our services, please feel free to contact us to discuss how we can be involved in your cellular therapy development program.

References:

1. Au, Patrick, et al. "FDA oversight of cell therapy clinical trials." Science translational medicine 4.149 (2012): 149fs31-149fs31.
2. Elverum, Kris, and Maria Whitman. "Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine." Gene therapy (2019): 1-8.
3. Schulman, Ivonne H., et al. "Unique Aspects of the Design of Phase I/II Clinical Trials of Stem Cell Therapy." The Management of Clinical Trials (2018): 55.