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Autologous stromal vascular fraction (SVF) cells from adipose tissue for knee osteoarthritis

Only two years ago 484 companies were developing regenerative biologic therapies to treat a wide number of diseases and conditions [1]. Today even more  companies are developing regenerative biologic therapies, including cellular therapies, to address an even greater number of diseases and conditions. The premise for a cellular approach is that using cells results in a therapy that achieves clinical outcomes not achievable with drugs or devices by leveraging a natural biologic function and interactions of the cells.  

At GID BIO, we are developing cell therapies based on use of stromal and vascular cells derived from your own adipose tissue. Our primary focus is development of a cell therapy using autologous stromal vascular fraction cells derived from adipose tissue for treatment of knee pain caused by osteoarthritis.  

How our cellular implant is produced 

The procedure is performed in a six-step process at the point-of-care:

 

  1. A physician harvests 30cc-50cc of
     adipose (fat) tissue from a patient’s abdomen or flanks using only local anesthetic
  2. The tissue is washed using a high-efficiency system to eliminate leukocytes, erythrocytes, triglycerides, and analgesics
  3. The tissue is dissociated using an enzyme to free the stromal vascular fraction (SVF) cells from the tissue structures
  4. The isolated SVF cells are concentrated
  5. Cell yield and viability assays are completed for a consistent, characterized, and viable cellular implant
  6. The cellular implant is injected into the patient’s knee under image guidance 

Why use adipose (fat) tissue? 

Stromal and vascular cells are present in many tissues of the body, in different amounts and with different levels of access.  Adipose tissue is a uniquely valuable source for SVF cells for the following reasons:

  1. Adipose is the richest source of stromal and vascular cells per gram of tissue, resulting in the smallest amount of tissue that must be harvested to produce a therapeutic dose of SVF cells compared to other tissue sources
  2. Patients have an available amount of adipose tissue that can harvested without undue loss of function
  3. Adipose tissue is easily harvested using only minimally invasive techniques
  4. For the reasons listed above adipose tissue enables treatment at point-of-care and eliminates the need for cell culturing and cell expansion to generate therapeutic levels of cells 

Evaluation

Data published in the American Journal of Sports Medicine from a randomized, controlled clinical trial that evaluated the use of autologous stromal and vascular cells for osteoarthritis pain and function demonstrated that patients who received the cellular therapy experienced an 89% improvement in pain, stiffness and function that was statistically significant at one year compared to no improvement for a control group who received a placebo. Through two years, no serious or device-related adverse events were reported. 

What is different about our cellular implant?

Our cellular implant is derived from a patient’s own tissues, referred to as autologous cells, which eliminates a significant immune response in the patient that results when allogeneic (someone else’s) cells are used without control or immunosuppression. The cellular implant is derived at point-of-care using only minimally invasive techniques, eliminating the need for cell culturing and manufacturing that takes weeks and a second treatment for the patient. 

Learn more

We encourage you to join our community of orthopedic surgeons, sports medicine physicians, PM&R physicians, and leaders in regenerative medicine to receive updates as our cellular therapy is evaluated in an FDA-compliant pivotal/Phase III clinical trial.  

By applying a scientific and data-driven approach, our intent is to transform the treatment of osteoarthritis by providing significant pain relief that is durable and that can be delivered using only minimally invasive techniques. 

 

[1] Alliance for Regenerative Medicine. Jan 7, 2019: State of the Industry Briefing. http://alliancerm.org/wp-content/uploads/2019/01/State-of-the-Industry-2019-FINAL.pdf


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