Celltex Therapeutics is a biotechnology company based in Houston, Texas, specializing in regenerative medicine. Founded in 2011, its primary focus is the banking and expansion of an individual’s own mesenchymal stem cells (MSCs) for potential therapeutic applications.
The company’s services involve isolating, multiplying, and storing these adult stem cells, which are derived from the patient’s own body. This process provides quantities of cells for regenerative therapy, aiming to harness the body’s natural repair capabilities through personalized stem cell applications.
Understanding Celltex’s Stem Cell Process
Celltex obtains mesenchymal stem cells (MSCs) from a patient’s adipose, or fat, tissue. This process begins with a mini liposuction procedure to collect a small amount of abdominal fat. The collected adipose tissue is then transported to the Celltex laboratory facility within a 24-hour window, maintained at a temperature between 2°C and 8°C to preserve cell viability.
Once at the laboratory, MSCs are isolated from the adipose tissue using proprietary technology. These isolated cells then undergo “culture-expansion,” where they are multiplied in the laboratory. The goal is to significantly increase the number of MSCs, yielding quantities in the hundreds of millions for therapeutic applications.
The expansion process involves culturing the cells until they reach approximately 90% confluence, meaning they nearly cover the surface of their culture vessel. Expanded cells are then harvested, washed, and formulated in sterile saline for future use. Before banking, the final cellular products undergo quality control tests, including assessments for cell counts, viability, purity, identity, and microbial contamination, ensuring they meet specific standards.
A defining characteristic of Celltex’s process is its autologous nature, meaning the cells used for therapy are sourced from the patient’s own body. This approach aims to reduce the risk of immune rejection, a potential concern when using donated cells from another individual. The expanded MSCs can then be cryopreserved and stored for an extended period, allowing individuals to access their banked cells when needed for therapeutic purposes.
Applications of Celltex Therapies
Celltex Therapeutics offers its expanded mesenchymal stem cells for a range of health conditions and general wellness purposes. The company categorizes these intended uses into several broad groups, reflecting the diverse regenerative and immunomodulatory properties attributed to MSCs.
One significant area of focus is autoimmune disorders, where the body’s immune system mistakenly attacks its own healthy cells. Celltex aims to help individuals with conditions like rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, and Hashimoto’s disease by utilizing the immunomodulatory effects of MSCs.
Degenerative conditions, which involve the progressive deterioration of tissues or organs over time, also represent a key application. This includes orthopedic issues such as osteoarthritis of the knees, hips, and shoulders, as well as degenerative disc disease. Neurological disorders are another target, with potential applications for conditions like Parkinson’s disease, dementia, and dysautonomia.
Vascular diseases, which involve abnormal conditions of the blood vessels, are addressed by Celltex’s therapies. This includes conditions like critical limb ischemia and Raynaud’s disease, where improving circulation and tissue repair is a goal. Beyond specific diseases, Celltex also promotes the use of MSCs for general wellness and anti-aging purposes.
Navigating the Regulatory Environment
The regulatory status of stem cell therapies, particularly those involving expanded cells, is a complex area in the United States, where the Food and Drug Administration (FDA) oversees human cell and tissue products (HCT/Ps). The FDA regulates HCT/Ps, which outlines requirements for manufacturing, processing, packaging, and storing these products.
Under these regulations, HCT/Ps that undergo more than minimal manipulation or are intended for non-homologous use (meaning used for a different function in the recipient than in the donor) are generally considered biological drug products. As such, they require FDA approval for specific uses, similar to other drugs, which typically involves demonstrating safety and effectiveness through clinical trials.
Celltex’s process of expanding autologous mesenchymal stem cells is viewed by the FDA as more than minimal manipulation. This means that, according to the FDA’s interpretation, Celltex’s expanded MSCs are considered drugs and would require an Investigational New Drug (IND) application and subsequent marketing approval for each specific therapeutic indication.
Celltex has historically disagreed with the FDA’s classification of their expanded autologous MSCs as biological drugs, arguing that identical copies of an individual’s own stem cells should not be subject to such regulation. Despite this, the company has indicated a willingness to work with the FDA to find a compliant regulatory pathway, including developing products under IND applications. Currently, Celltex has initiated or participated in clinical trials, such as a Phase 2 study for osteoarthritis of the knees, hips, and shoulders, which aligns with the FDA’s requirement for clinical investigation of unapproved drug products.