1. What is an EMC?
EMC stands for Educated Mesenchymal Cells. While there have been many clinical trials using mesenchymal stem cells (MSCs) over the last ten years, they have used MSCs that have not been directed to adopt an immunosuppressive behavior before they are given to a patient. Thus, only a fraction of the cells may eventually adopt the right behavior after a delayed period, depending on what in vivo cues they experience.
EMCs are MSCs that have been trained to be homogenously immunosuppressive before they are clinically administered.
2. Are EMCs really that different from regular MSCs?
Relative expression of >3000 proteins between EMCs and uneducated MSCs.
3. How do EMCs compare with anti-inflammatory drugs?
Many diseases, both acute and chronic, involve an unwanted immune response (autoimmune disease, organ rejection, acute inflammation etc.). The immune cells directly contribute to disease progression, and not surprisingly, the common denominator for treating these conditions involves drugs like steroids, calcineurin inhibitors, cyclophosphamide, methotrexate, and wide variety of new biologic agents. Unfortunately, these drugs tend to have lengthy side effect profiles, including but not limited to: diabetes, skin changes, body mass redistribution, psychosis, mouth sores, liver problems, kidney disease, anemia, and opportunistic infections. Once educated to become EMCs, MSCs have been shown to subdue active immune cells. Rather than targeting one protein or receptor, as is the case with most drugs, EMCs produce a variety of immunosuppressive proteins that act at multiple nodes in the immune response. This gives them their immunosuppressive effect without profound disruption of a single point. Furthermore, they can promote cells that can induce immune tolerance.
4. Are EMCs safe?
There have been numerous clinical trials of MSCs from a wide variety of source tissues. They are generally thought to have a strong safety profile with minimal adverse events. From the regulatory (safety) perspective, EMCs are not that different from “regular” MSCs. However, each small variation and application still needs to be tested and approved.
5. How do you differ from other MSC companies?
As per our science page, over the last 10 years, a great deal has been learned about how to instruct MSCs to adopt an anti-inflammatory phenotype. The scientific founders of IMMPLACATE, themselves, have over five years of first-hand experience with optimizing this “educational program”, which is reflected in the technology we use to make our EMC. We believe this difference will lead to superior performace of EMCs in clinical trials compared with the regular MSCs use by other companies.
6. Where does the treatment occur?
While we are currently pre-clinical stage, future clinical trials will be hosted at academic medical centers.
7. How will it be reimbursed?
Since MSCs/EMCs are not FDA approved yet, they do not have a specific reimbursement code with Medicare or private insurers.
Nevertheless, there are some indirect routes towards coverage that we anticipate will cover the cost of the treatments in the first years following approval. We initially plan to target a complication of bone marrow transplantation called graft-vs-host-disease (GvHD). Generally, hospitals will receive a bundle payment for the bone marrow transplant, which is meant to cover the cost of any post-transplant complications such as GvHD. Thus, it is up to an individual hospital’s discretion as to how they spend the money.
As compelling clinical data emerge, we will work with insurance agencies to advocate for specific coverage of MSCs, which will help with their reimbursement when their application is widened to other clinical indications.