Frequently Asked Questions
What is Regenerative Medicine?
Regenerative medicine is the process of replacing and/or renewing human cells, tissues, organs, proteins, etc., for the purposes of restoring function and homeostasis in the body. One of the key components of regenerative medicine is the use of cell replacement strategies, which usually requires stem cells.
What is Stromal Vascular Fraction / Cell Therapy?
These are undifferentiated cells in our bodies that have the capacity to change into any healthy cell. This means that stem cells can change into skin, bone, heart, and muscle cells, to name a few. They have the ability to replicate substantially, as compared to normal somatic cells such as skin. Stem cells are located throughout our body in almost every organ and tissue such as bone marrow, fat, teeth, muscles, etc.
What does the latest research indicate regarding the capabilities and effectiveness of stem cells for regenerative medicine?
Stem cells are undifferentiated cells that have the capacity to change into any specific cell type in the body. These cells, once deployed to an area of injury/disease, can readily change into the cell type that needs to be replaced. Moreover, stem cells home to sites of injury by cell signals that attract them to these locations. Once the stem cells reach where they need to go, they dock and commence repairing the injury/disease by releasing cytokines, chemokines, and growth factors that aid in host endogenous repair. There are greater than 200,000 peer-reviewed scientific publications on PubMed, with thousands discussing positive outcomes following the use of stem cells. The publication topics range from stem cell therapies for heart disease to osteoarthritis to diabetes, to name a few.
Why is this easy for physicians to use?
Our product has one of the highest cell counts in the market today, adhering to sterility, traceability and viability. The product can be applied according to your specific protocols or patients’ needs. We also have the ability to cryo-preserve these cells. Our product is strictly compliant with FDA standards under Current Good Manufacturing Practice (cGMP) regulations. We take pride in the quality and reliability of our product.
How are we committed to safety?
We use only your stem cells and there is no risk of an immune rejection. Moreover, the product contains no known proteins, enzymes, growth factors or collagenase and we maintain total cell composition throughout the process. Our regenerative medicine product is produced in compliance with FDA cGMP (Current Good Manufacturing Practice) and GTP (Good Tissue Practices) standards, which assures you, the end user, quality and safety in our product. Most importantly, our regenerative medicine product is minimally manipulated, preserving its natural healing properties.
What else can you tell us?
Our Philosophy:
We provide the highest-quality human cell and tissue products (HCT/P) to our physician customers and their patients.
Moving Forward:
Advances in the procurement and processing of human cell and tissue will allow Advanced Therapeutic Lab to establish a strong pipeline of revolutionary Human Cell and Tissue Products (HCT/P) for regenerative medicine applications.
Compliance:
We are an FDA-registered, cGMP-/cGTP-compliant lab, in accordance with federal good manufacturing requirements (cGMP) and tissue practices (cGTP). Good Tissue Practice (GTP) is the term used to refer to the FDA regulations for stem cells and tissue. Good Manufacturing Practice (GMP) refers to the FDA regulations for drug products. GTP rules require that systems are in place to prevent the introduction, transmission or spread of communicable disease. GMP rules ensure safe, pure and effective drug products.
Treatments and Research:
Regenerative therapy is the practice of delivering cells and cell products to renew diseased or damaged tissues in a specific area. It is one of the fastest-growing fields of medical research. Each year, new regenerative therapies using cellular therapy enter into clinical trials for the treatment of chronic and life-threatening diseases. If proven successful, these clinical trials will lead to approval from the Food and Drug Administration (FDA). With FDA approval, these treatments can then be administered as a general practice.