EDUCATION
UNDERSTANDING CELLULAR THERAPY
One technology platform and a team of experts is committed to making safe, effective cellular therapy available to everyone. This step means less procedure time, recovery time and pain for patients and less cost burden on our healthcare system.
HARNESSING THE POWER OF CELLS
Our bodies have 37 trillion cells with hundreds of different types, many of which are healing and regenerative. By identifying and utilizing those cells, the SVF-2 device and corresponding procedure will act as a catalyst for the body to start healing itself intelligently.
FREQUENTLY ASKED QUESTIONS
MARKETPLACE FOR CELLULAR THERAPY TO TREAT OSTEOARTHRITIS OF THE KNEE
WHY IS TACKLING OA A PRIORITY?
- Costs attributed to OA significantly burden the US healthcare system. Total costs average almost $200 billion each year.2 Therapy costs (TKR, viscosupplementation, steroid injection) exceed $50 billion annually in the US.
- More than 700,000 total knee replacement surgeries are performed in the United States annually.3
- In the last decade, the number of total knee replacements performed annually in the United States has doubled.4
HOW MANY PEOPLE DOES OA AFFECT IN THE US?
- OA affects over 27 million adults in the U.S.1
CELLULAR THERAPY
DO CELLULAR THERAPIES USE ONLY STEM CELLS?
- The stromal cells isolated from adipose tissue are a heterogeneous mix of cell types, including a small naturally occurring concentration of stem cells.
WHAT’S THE SIGNIFICANCE OF USING ADIPOSE TISSUE? WHAT IS THE DIFFERENCE BETWEEN ADIPOSE TISSUE AND BONE MARROW?
- Bone marrow aspirate contains mostly hematopoietic cells (blood cells, CD45+), which are not useful for repairing stromal or vascular tissues. A very small proportion (<0.1%) of the cells in bone marrow aspirate are mesenchymal stem cells — which are capable of stromal and vascular tissue repair/regeneration. But because of the small quantity of bone marrow harvest and the very low proportion of mesenchymal cells, bone marrow harvest requires culturing to isolate and expand the numbers of mesenchymal stem cells to support a regenerative therapeutic treatment and to eliminate the hematopoietic cell fraction in the harvest. Adipose tissue, by comparison, is a far richer source of nucleated stromal cells, having typically 500 times more nucleated stromal cells (not blood cells) per cc of harvest than bone marrow aspirate. No culturing is needed when using adipose as the harvest tissue because adipose can produce a therapeutic dose of nucleated stromal cells from a small tissue sample.
WHAT IS THE DIFFERENCE BETWEEN USING YOUR OWN CELLS (AUTOLOGOUS CELLS) AND SOMEONE ELSE’S CELLS (ALLOGENIC CELLS)?
- The body precisely tolerates its own autologous cells but has a very strong immune reaction to cells that are not its own. Autologous cells are preferred for regenerative therapy because they are precisely tolerated in your body.
WHAT’S THE SIGNIFICANCE OF USING OUR OWN CELLS?
- Autologous cells (your own cells) eliminate the immune response and rejection of the cellular implant compared to allogeneic cells (someone else’s cells).
WHY IS CELLULAR MEDICINE AN IMPORTANT TREATMENT OPTION FOR PATIENTS?
- Cellular-based medicine, and more specifically autologous cellular implants (your own cells), are a new era of medicine, distinct from molecular (drug) and surgical solutions.
- Existing therapies for OA include short-term symptomatic pain relief from hyaluronic acid and corticosteroid injections and total knee replacement for severe OA.
STEM CELLS
WHAT ARE THE LIMITATIONS OF STEM CELLS FROM BLOOD?
- Blood stem cells (hematopoietic stem cells, or HSC’s) can only repair or replace the cells of the blood. Blood stem cells can generate three general types of blood cells: leukocytes (white blood cells), erythrocytes (red blood cells), and platelets. HSC’s are thus not capable of repairing stromal or vascular structures or tissues in the body.
WHY ARE STEM CELLS CULTURED?
- The number of stem cells present in almost any tissue harvest is typically very small. When tissue is harvested a great number of nucleated cells are collected, but only a very small percentage of those nucleated cells are stem cells. Thus, the harvested cells must be cultured (grown in favorable, controlled conditions) to increase the number of stem cells needed for a therapeutic dose.
CAN STEM CELLS REGENERATE ANY KIND OF TISSUE?
- Adult stem cells have a very limited capacity to differentiate along different lineages. For example, adult mesenchymal stem cells derived from adipose tissue cannot become brain, heart or kidney tissues, but can become adipose (adipogenesis), bone (osteogenesis), or cartilage (chondrogenesis).
WHAT IS AN ADULT STEM CELL?
- Adult stem cells are ‘unspecialized or undifferentiated cells’ that have the capacity to differentiate into a limited number of related cell types. Stem cells also have the property that they can replicate themselves a large number of times. Mature cells, by contrast, are fully differentiated into a specific cell type, and represent a much larger proportion of the cells in your body. Mature cells cannot differentiate into related cell types and usually have a very limited capacity to replicate.
TOTAL KNEE REPLACEMENT
DO YOU HAVE ANY INFORMATION ABOUT TOTAL KNEE REPLACEMENT?
- Total knee replacement costs average over $50,000 per procedure5 and vary widely.
- About 1 in 20 (5%) patients experience significant complications following total knee replacement surgery.6
- Patients undergoing total knee replacement surgery undergo a prolonged recovery time.7
- Nearly 20% of TKR patients continued to work fewer hours 1-year postoperatively.8
THE GID SVF-2 DEVICE AND THERAPY
WHAT IS THE MECHANISM OF ACTION (MOA)?
- For a chronic degenerative disease such as osteoarthritis, endogenous stromal cells (those that reside in the diseased tissue that play an essential role in tissue maintenance, repair, and remodeling) are unable to achieve regulation of the healing process. GID technology supplements the endogenous stromal cell population with exogenous stromal cells derived from the patient’s adipose tissue.
HOW DOES GID’S DEVICE AND THERAPY WORK?
- The SVF-2 technology isolates and concentrates the stromal cells from a patients’ own adipose tissue, significantly eliminating parenchymal cells (adipocytes), blood cells, and extracellular matrix.
CLINICAL DATA AND RESULTS
WHAT CLINICAL DATA EXISTS?
Phase IIb Study
- In GID’s randomized controlled Phase IIb trial (FDA-approved IDE trial) 88% of the patients responded greater than the placebo control and reported a median 85% improvement in pain, stiffness and function at one year.
- All prespecified endpoints in the trial were met.
- No serious adverse events were reported.
- The treatment group was statistically significant relative to the placebo group at 6 months and at one year.
- Published results in American Journal of Sports Medicine. The published paper “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial”.
- See ClinicalTrials.gov for a link to our study “Adipose-derived SVF for the Treatment of Knee OA”
Safety and Feasibility Studies
Click on the links below to see the results of early safety and feasibility studies:
REIMBURSEMENT
ARE YOU WORKING WITH PAYERS FOR INSURANCE COVERAGE?
- The AMA issued two CPT T-codes, 0565T and 0566T, for Medicare reimbursement for the GID device and therapy to treat OA of the knee. These codes were announced 7/1/19 and become effective 1/1/20.
WHO ARE GID BIO?
ARE THERE OTHER APPLICATIONS FOR THE SVF-2 DEVICE? WHAT’S NEXT AFTER KNEE TREATMENTS FOR OA?
- GID is working on extension of its treatment for OA of the knee to OA of the shoulder and OA/RA of the hands. The pipeline also includes development of therapies for dermal/integument (subcutaneous) conditions such as PVD (large and small vessel), diabetic ulcers, burns/scars, and radiation injury.
WHAT DOES IT MEAN TO “HEAL INTELLIGENTLY” ?
- Your cells have an innate ability to dynamically participate in a complex interactive healing process. We create cellular implants that utilize this innate ability to heal and call this “healing intelligently.”
WHY DID GID INITIALLY FOCUS ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE?
- Treating OA is a huge unmet need. There is no cure for OA and currently 30 million Americans suffer from OA, half of them with OA of the knee.
References
- Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013;21(9):1145-1153. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3753584/
- Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009;60(12):3546-3553. Link: https://www.ncbi.nlm.nih.gov/pubmed/19950287
- Martin GM. Patient education: total knee replacement (arthroplasty) (beyond the basics). UpToDate website. Published June 2017. Accessed November 15, 2017. Link: https://www.uptodate.com/contents/search?search=total-knee-replacement-arthroplasty-beyond-%20the-basics
- Weinstein AM, Rome BN, Reichmann WM, et al. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013;95(5):385-392. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3748969/
- Greengard S. Understanding knee replacement costs: what’s on the bill? Healthline website. Published October 2017. Accessed November 15, 2017. Link: https://www.healthline.com/health/total-knee-replacement-surgery/understanding-costs#1
- Knee replacement surgery. Arthritis Research UK website. Published June 2015. Accessed November 15, 2017. Link: https://www.versusarthritis.org/
- Greengard S, Carey E. Recovery timeline for TKR: rehabilitation stages and physical therapy. Healthline website. Published May 2017. Accessed November 15, 2017. Link: https://www.healthline.com/health/total-knee-replacement-surgery/rehabilitation-timeline
- Tilbury C, Leichtenberg C. S., Tordoir R. L. Return to work after total hip and knee arthroplasty: results from a clinical study. Rheumatol Int. 2015; 35(12): 2059–2067. Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4651988/
Have a practitioner login? Click [here] to access the SVF-2 training portal.
EDUCATION
UNDERSTANDING CELLULAR THERAPY
HARNESSING THE POWER OF CELLS
Our bodies have 37 trillion cells with hundreds of different types, many of which are healing and regenerative. By identifying and utilizing those cells, the SVF-2 device and corresponding procedure will act as a catalyst for the body to start healing itself intelligently.
MARKETPLACE FOR CELLULAR THERAPY TO TREAT OSTEOARTHRITIS OF THE KNEE
WHY IS TACKLING OA A PRIORITY?
- Costs attributed to OA significantly burden the US healthcare system. Total costs average almost $200 billion each year.2 Therapy costs (TKR, viscosupplementation, steroid injection) exceed $50 billion annually in the US.
- More than 700,000 total knee replacement surgeries are performed in the United States annually.3
- In the last decade, the number of total knee replacements performed annually in the United States has doubled.4
HOW MANY PEOPLE DOES OA AFFECT IN THE US?
- OA affects over 27 million adults in the U.S.1
CELLULAR THERAPY
DO CELLULAR THERAPIES USE ONLY STEM CELLS?
- The stromal cells isolated from adipose tissue are a heterogeneous mix of cell types, including a small naturally occurring concentration of stem cells.
WHAT’S THE SIGNIFICANCE OF USING ADIPOSE TISSUE? WHAT IS THE DIFFERENCE BETWEEN ADIPOSE TISSUE AND BONE MARROW?
- Bone marrow aspirate contains mostly hematopoietic cells (blood cells, CD45+), which are not useful for repairing stromal or vascular tissues. A very small proportion (<0.1%) of the cells in bone marrow aspirate are mesenchymal stem cells — which are capable of stromal and vascular tissue repair/regeneration. But because of the small quantity of bone marrow harvest and the very low proportion of mesenchymal cells, bone marrow harvest requires culturing to isolate and expand the numbers of mesenchymal stem cells to support a regenerative therapeutic treatment and to eliminate the hematopoietic cell fraction in the harvest. Adipose tissue, by comparison, is a far richer source of nucleated stromal cells, having typically 500 times more nucleated stromal cells (not blood cells) per cc of harvest than bone marrow aspirate. No culturing is needed when using adipose as the harvest tissue because adipose can produce a therapeutic dose of nucleated stromal cells from a small tissue sample.
WHAT IS THE DIFFERENCE BETWEEN USING YOUR OWN CELLS (AUTOLOGOUS CELLS) AND SOMEONE ELSE’S CELLS (ALLOGENIC CELLS)?
- The body precisely tolerates its own autologous cells but has a very strong immune reaction to cells that are not its own. Autologous cells are preferred for regenerative therapy because they are precisely tolerated in your body.
WHAT’S THE SIGNIFICANCE OF USING OUR OWN CELLS?
- Autologous cells (your own cells) eliminate the immune response and rejection of the cellular implant compared to allogeneic cells (someone else’s cells).
WHY IS CELLULAR MEDICINE AN IMPORTANT TREATMENT OPTION FOR PATIENTS?
- Cellular-based medicine, and more specifically autologous cellular implants (your own cells), are a new era of medicine, distinct from molecular (drug) and surgical solutions.
- Existing therapies for OA include short-term symptomatic pain relief from hyaluronic acid and corticosteroid injections and total knee replacement for severe OA.
STEM CELLS
WHAT ARE THE LIMITATIONS OF STEM CELLS FROM BLOOD?
- Blood stem cells (hematopoietic stem cells, or HSC’s) can only repair or replace the cells of the blood. Blood stem cells can generate three general types of blood cells: leukocytes (white blood cells), erythrocytes (red blood cells), and platelets. HSC’s are thus not capable of repairing stromal or vascular structures or tissues in the body.
WHY ARE STEM CELLS CULTURED?
- The number of stem cells present in almost any tissue harvest is typically very small. When tissue is harvested a great number of nucleated cells are collected, but only a very small percentage of those nucleated cells are stem cells. Thus, the harvested cells must be cultured (grown in favorable, controlled conditions) to increase the number of stem cells needed for a therapeutic dose.
CAN STEM CELLS REGENERATE ANY KIND OF TISSUE?
- Adult stem cells have a very limited capacity to differentiate along different lineages. For example, adult mesenchymal stem cells derived from adipose tissue cannot become brain, heart or kidney tissues, but can become adipose (adipogenesis), bone (osteogenesis), or cartilage (chondrogenesis).
WHAT IS AN ADULT STEM CELL?
- Adult stem cells are ‘unspecialized or undifferentiated cells’ that have the capacity to differentiate into a limited number of related cell types. Stem cells also have the property that they can replicate themselves a large number of times. Mature cells, by contrast, are fully differentiated into a specific cell type, and represent a much larger proportion of the cells in your body. Mature cells cannot differentiate into related cell types and usually have a very limited capacity to replicate.
TOTAL KNEE REPLACEMENT
DO YOU HAVE ANY INFORMATION ABOUT TOTAL KNEE REPLACEMENT?
- Total knee replacement costs average over $50,000 per procedure5 and vary widely.
- About 1 in 20 (5%) patients experience significant complications following total knee replacement surgery.6
- Patients undergoing total knee replacement surgery undergo a prolonged recovery time.7
- Nearly 20% of TKR patients continued to work fewer hours 1-year postoperatively.8
THE GID SVF-2 DEVICE AND THERAPY
WHAT IS THE MECHANISM OF ACTION (MOA)?
- For a chronic degenerative disease such as osteoarthritis, endogenous stromal cells (those that reside in the diseased tissue that play an essential role in tissue maintenance, repair, and remodeling) are unable to achieve regulation of the healing process. GID technology supplements the endogenous stromal cell population with exogenous stromal cells derived from the patient’s adipose tissue.
HOW DOES GID’S DEVICE AND THERAPY WORK?
- The SVF-2 technology isolates and concentrates the stromal cells from a patients’ own adipose tissue, significantly eliminating parenchymal cells (adipocytes), blood cells, and extracellular matrix.
CLINICAL DATA AND RESULTS
WHAT CLINICAL DATA EXISTS?
Phase IIb Study
- In GID’s randomized controlled Phase IIb trial (FDA-approved IDE trial) 88% of the patients responded greater than the placebo control and reported a median 85% improvement in pain, stiffness and function at one year.
- All prespecified endpoints in the trial were met.
- No serious adverse events were reported.
- The treatment group was statistically significant relative to the placebo group at 6 months and at one year.
- Published results in American Journal of Sports Medicine. The published paper “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial”.
- See ClinicalTrials.gov for a link to our study “Adipose-derived SVF for the Treatment of Knee OA”
Safety and Feasibility Studies
Click on the links below to see the results of early safety and feasibility studies:
WHO IS GID?
ARE THERE OTHER APPLICATIONS FOR THE SVF-2 DEVICE? WHAT’S NEXT AFTER KNEE TREATMENTS FOR OA?
- GID is working on extension of its treatment for OA of the knee to OA of the shoulder and OA/RA of the hands. The pipeline also includes development of therapies for dermal/integument (subcutaneous) conditions such as PVD (large and small vessel), diabetic ulcers, burns/scars, and radiation injury.
WHAT DOES IT MEAN TO “HEAL INTELLIGENTLY” ?
- Your cells have an innate ability to dynamically participate in a complex interactive healing process. We create cellular implants that utilize this innate ability to heal and call this “healing intelligently.”
WHY DID GID INITIALLY FOCUS ON THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE?
- Treating OA is a huge unmet need. There is no cure for OA and currently 30 million Americans suffer from OA, half of them with OA of the knee.
References
- Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013;21(9):1145-1153.
- Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009;60(12):3546-3553.
- Martin GM. Patient education: total knee replacement (arthroplasty) (beyond the basics). UpToDate website. Published June 2017. Accessed November 15, 2017.
- Weinstein AM, Rome BN, Reichmann WM, et al. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013;95(5):385-392.
- Greengard S. Understanding knee replacement costs: what’s on the bill? Healthline website. Published October 2017. Accessed November 15, 2017.
- Knee replacement surgery. Arthritis Research UK website. Published June 2015. Accessed November 15, 2017.
- Greengard S, Carey E. Recovery timeline for TKR: rehabilitation stages and physical therapy. Healthline website. Published May 2017. Accessed November 15, 2017.
- Tilbury C, Leichtenberg C. S., Tordoir R. L. Return to work after total hip and knee arthroplasty: results from a clinical study. Rheumatol Int. 2015; 35(12): 2059–2067.
Have a practitioner login? Click [here] to access the SVF-2 training portal.
