An Automated Device for High Yield Mesenchymal Stem Cell Extraction

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Project Summary/Abstract This Phase II project aims to develop an automated system for extracting mesenchymal stem cells (MSCs, also known as multipotent stromal cells) from adipose tissues for treating many serious diseases, including myocardial infarction, graft-versus-host disease, and a variety of autoimmune diseases. Over 800 clinical trials to date have established the feasibility, safety, and in some cases efficacy of MSC therapies to treat these diseases. However, the results are inconclusive due to (1) the lack of reliable and optimized MSC preparation protocols, and (2) the loss of therapeutic potential as MSCs are extensively culture expanded. Based on its patent-pending technology, CG Scientific Inc. is developing an automated MSC-extraction system that provides high cell recovery and viability, while significantly reducing process variations, time, and costs. The company has successfully demonstrated in Phase I that its technology can deliver about 60−100 million MSCs in 45 minutes from a single adipose specimen, sufficient to provide a therapeutic dose of MSCs without culture expansion. This result represents a ~10x improvement in MSC output yield over competing products (due to ~4.2x in cell recovery and ~2.5x in MSC function) and opens the opportunity to use un-cultured primary MSCs as a high potency substitute for conventional culture-expanded MSCs. Without culture expansion, it becomes possible to produce sufficient therapeutic amounts of MSCs in less than 1 hour (as opposed to 4-6 weeks conventionally) and administer the MSCs autologously in the same day. The automated system has a unique configuration to (1) enable efficient enzyme digestion, (2) integrate multiple MSC extraction steps in a closed-system format, (3) fully automate the MSC extraction process, and (4) overcome conventional limitations of enzymatic cell extraction. Using the technology, high quality MSCs can be produced in clinically relevant quantities quickly, safely, and reproducibly. In Phase II, the company will (1) develop a final product prototype to work out manufacturing details and further optimize MSC recovery performance, (2) characterize the new system and prepare data for FDA submission, and (3) demonstrate the pre-clinical efficacy and the superior performance of the new system against competing products. The investigator team includes medical device experts, stem cell biologists, engineers and medical doctors who have worked together successfully. This project will result in the realization of an essential tool that has the potential to make MSC therapies highly effective and practical for treating many life-threatening and hard-to-treat diseases.