Systemic Laboratories processes tissue for physicians with significant advantages over other laboratories and certainly over processing tissue within your practice. We are an FDA-registered tissue processing lab in compliance with FDA regulations, the Public Health Service (PHS) Act, Current Good Tissue Practice (cGTP) and Current Good Manufacturing Practice (cGMP).
What to Expect From Our Process:
In the physician’s office or a same-day surgery center, physicians can harvest tissue using a minor harvesting procedure. The tissue is placed in a special transport bag with ice packs and transported under sterile conditions, in a temperature-controlled box, to our facility in Great Neck on Long Island. Upon arrival at our tissue processing lab, the specimen is processed by state-of-the-art stem cell technology under biosafety cabinets and using cell counters, in a proprietary protocol into stromal vascular fractions (SVF).
- Our unique technique yields a higher volume of SVF than other processes.
- We do not use enzymes, nor do we manipulate, expand or multiply tissues or cells.
- Detailed reports are provided on cell counts including gross, nucleoid and stem cells.
- Cryogenic, short-term storage may be available at -80 degrees.
- Samples are tracked from collection through retrieval with a compliant inventory control and monitoring system.
We also provide administrative, technical and clinical support. We welcome questions and strive to provide fast and complete answers to any of your concerns.
Systemic Laboratories is also registered for umbilical cord blood processing where we can wash autologous, cord blood cells using the Duke protocol prior to administration by a physician.
Systemic Laboratories is the Lab of choice for National Stem Cell Centers and leading cord blood laboratories. We are part of an IND application with the FDA for the treatment of joint pain using autologous, adipose cells.
How We Adhere to Regulations:
If you utilize our Lab, we know that it’s only because we’ve earned your trust. We also understand the significant liabilities that we and our physicians will face if something goes wrong. Our corporate values stress the highest standards of integrity and ethics in our services to our physicians. We are dedicated to full transparency in our processes while ensuring full patient privacy throughout our business.
We never sit on our laurels. We regularly review our policies and practices, revising upward whenever we see improvements can be made. We guarantee that we are in full compliance with applicable federal, state or local statute and regulation.
Questions? Contact Us Now!
With the rapid growth of regenerative medicine, physicians need to partner with facilities that are reliable and current on the ongoing research in stem cells and their potential. Contact Systemic Laboratories, we welcome your questions about our services and we’re standing by to schedule an appointment to assist you.