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Cell Therapy

What are stem cells?
    Stem cells serve as the starting material of the body and are the precursor to all other cell types. Stem cells are unspecialized cells capable of transforming into a range of other cell types but also able to replicate themselves to produce more stem cells. The body uses stem cells to heal and regenerate tissues by activating the stem cells to mature into the type of cell needed by the body.
What are vaPS cells?
    Vascular- associated pluripotent stem cells (vaPS cells) are at the core of tissue regeneration. They have the potential to develop into cells of all three germ layers (mesoderm, ectoderm, and endoderm) and are distributed throughout the body’s blood vessels. vaPS cells are suspected to be the precursor of all stem cell types found in the adult body and give rise to various progenitor cells that further differentiate into the mature cell type in need of regeneration.
What is stem cell therapy?
  • Like the phrase “stem cell” itself, “stem cell therapy” is often used to describe a variety of different medical therapies that utilize stem cells in some form to treat a patient. Sometimes the term is used incorrectly to refer to platelet rich plasma (PRP) injections. The term is also used to refer to stem cell transplants, also known as bone marrow transplants.
  • Most commonly “stem cell therapy” is used to describe a procedure where the patient’s adult stem cells and other potentially regenerative cells are harvested from a tissue sample of either fat or bone marrow taken from the patient. These regenerative cells are then used to treat specific injuries typically by injecting them into the affected area. It should be said that this type of stem cell therapy is currently not FDA approved and clinics performing these therapies in the US are doing so without regulatory oversight.
  • At InGeneron we use the term “regenerative cell therapy” since there are many different cell types and regenerative properties collected and used by our therapy along with adult stem cells. Importantly we do not treat patients outside of our approved clinical trials and we are dedicated to developing ethical FDA approved therapies through rigorous clinical research.
What is the difference between InGeneron’s regenerative cell therapy and “stem cell therapy”?
  • At InGeneron we use the term “regenerative cell therapy” since there are many different regenerative cell types with different regenerative properties collected and used by our therapy.
  • There are many different variations of what is commonly called “stem cell therapy”. More information about the differences and nuances of “stem cell therapy” can be found in the Cell Therapy page.
  • Importantly we do not treat patients outside of our approved clinical trials and we are dedicated to developing FDA approved therapies through rigorous clinical research.
Are stem cell therapies FDA approved?
  • The FDA has approved a very limited number of stem cell treatments as explained in the quote below.
    “Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the “hematopoietic” system) but they are not approved for other uses.” (Source:https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes).
  • Aside from the few treatments listed above, there are no FDA approved cell therapies outside of FDA registered clinical studies and all clinics in the US currently offering “stem cell therapy” outside of those trials are in violation of FDA regulations.
  • At InGeneron we are dedicated to following the proper FDA approval pathway. We are currently conducting three FDA-approved clinical studies and are on track to become the first FDA approved regenerative cell therapy for the treatment of orthopedic indications.
What are adipose-derived regenerative cells (ADRCs)?
  • Regenerative cells are cell types that naturally promote tissue regeneration and homeostasis by facilitating the generation of new cells to replace old or injured cells in a particular tissue. Adipose-derived regenerative cells, also known as Stromal Vascular Fraction, are cells isolated from adipose (fat) tissue, where they are found in high concentrations. Regenerative cells include stem cells, notably vaPS cells, and MSCs, which can mature into multiple cell types, progenitor cells, macrophages, and other cell types that promote tissue regeneration and healing.
  • These cells work together by responding to inputs from their surrounding through a complex system of signaling, resulting in synergistic healing effects that are greater than the effect that any one cell type can have on its own.
  • Multiple studies show that ADRCs can be effective in treating a variety of soft tissue and bone conditions and have a high safety profile.
How do corticosteroid injections and pain killers compare to regenerative cell therapy?
  • Regenerative cell therapy has the potential to be an effective treatment for a broad range of medical conditions. At InGeneron our initial focus is developing therapies to treat patients suffering from orthopedic conditions.
  • The most common treatment options for patients experiencing pain and lack of function due to an orthopedic condition is to mitigate the symptoms using pain killers, and steroid injections, which only offer temporary relief and don’t treat underlying tissue damage. For example the repetitive application of corticosteroids may actually weaken tendon tissue over time because of its known effect of blocking a key transcription factor (scleraxis) necessary for tendon regeneration.
  • Regenerative cell therapy has the potential to regenerate damaged tissue responsible for pain and lack of function eliminating the need for long term pain killer use and steroid injections, especially for less severe tissue damage where surgery is not recommended.
Surgical intervention compared to regenerative cell therapy.
  • Cell therapy aims to expand the treatment options for many indications by providing a minimally invasive alternative to orthopedic surgery and joint replacement. Cell therapies may not be the best treatment for all conditions but for many patients who are considering surgery to address an orthopedic condition, cell therapy may offer a valuable alternative with the potential to avoid surgical intervention in many cases.
  • For patients with minor orthopedic injuries the success of surgical intervention is often low and has the potential to do more harm than good by increasing inflammation and promoting the formation of scar tissue. Cell therapy aims to provide a minimally invasive treatment option for patients before they resort to surgical intervention.
  • Ultimately all surgeries rely on the body’s natural regenerative processes to heal the tissue manipulated during surgery. Therefore, surgical outcomes vary widely for many patients. For chronic degenerative diseases where the regenerative potential of the damaged tissue is exhausted surgical intervention will not solve the underlying condition whereas cell therapy attempts to replenish the regenerative cells of the affected tissue.
What is platelet-rich-plasma (PRP) and how does it compare to regenerative cell therapy?
    PRP introduces growth factors (GFs) to stimulate tissue regeneration but for many conditions, the underlying regenerative cells which are stimulated by the GFs are depleted and therefore PRP cannot be effective for many patients because it is like fertilizing a field that has not been planted. Cell therapy is more fundamental, generating similar GFs along with the necessary raw material for the GFs to act upon. Furthermore, cell therapy introduces cells that continue to generate GFs for a long period of time but PRP only introduces GFs in a onetime treatment that lasts as long as the GFs themselves and are not renewed.

InGeneron’s Transpose® RT Cell Therapy Platform

What makes Transpose® RT different from other types of cell therapy?
  • Autologous vs Allogenic: InGeneron’s cell therapy platform, Transpose® RT, utilizes a patient’s autologous regenerative cells. Autologous means the cells are taken from and reintroduced into the same patient. Using autologous cells prevents the risk of transplant rejection reactions that can be associated with allogenic cell therapies, which typically utilize donor cells that have been cultured in a lab.
  • Living Cell Yield: Transpose® RT utilizes a proprietary enzymatic isolation process, resulting in the highest published living cell yield compared to other autologous adipose-derived cell processing systems.
  • Unmodified vs. Modified: Transpose® RT utilizes unmodified regenerative cells, which are isolated from the patient’s own adipose tissue within two hours prior to re-introduction into the same patient for treatment. The cellular isolation process does not more than minimally manipulate the regenerative cells and maintains the composition of regenerative cells naturally occurring in the body.
Why use a patients adipose (fat) tissue?
  • Adipose tissue or body fat is an abundant and easily accessible source of regenerative cells. Harvesting adipose tissue and isolating ADRCs is less invasive than other stem or regenerative cell removal techniques such as bone marrow aspirations, and it yields significantly more stem cells per unit volume than bone marrow.
  • Treatment with autologous (i.e., the patient’s own) ADRCs isolated from the patient’s adipose tissue avoids common transplantation issues, such as the rejection of cells or the transmission of disease. Thus, the application of autologous ADRCs does not require any drugs that prevent transplant rejection reactions.
How does the Transpose® RT platform work?
  • Aging, disease, and injury can deplete the reservoir of regenerative cells in a specific tissue, limiting that tissue’s ability to regenerate itself. InGeneron’s solution to this problem is to take regenerative cells from tissues where they are abundant and provide them to the tissues where they have been depleted. InGeneron’s cell therapy platform accomplishes this by isolating regenerative cells from a small sample of a patient’s adipose (fat) tissue, where regenerative cells are numerous, and reintroducing them into the tissue in need of repair.
  • The Transpose® RT cell therapy platform isolates regenerative cells from a small sample of the patient’s adipose (fat) tissue harvested by mini-liposuction. The regenerative cells are separated from the adipose tissue using a proprietary enzymatic process. Once isolated the regenerative cells are washed and filtered to remove any contaminants. The result is a cleaned and concentrated solution of living, autologous, regenerative cells that are not more than minimally manipulated and able to be locally injected to promote the patient’s tissue regeneration at a specific site.
What is the Transpose® RT process?
  • A small sample of adipose tissue, containing regenerative cells, is taken from the patient using a mini-liposuction procedure. The sample is then transferred into a processing tube of the Transpose ® RT kit, and the proprietary Matrase ™ enzymatic reagent is added to the sample before it is inserted into the Transpose® RT Processing Unit. During the first run, efficient enzymatic extracellular degradation liberates the regenerative cells from their surrounding matrix. Subsequent washing and filtering steps prepare these cells for immediate therapeutic application. The entire procedure can be completed within a few hours in an outpatient facility.
Does the Transpose® RT platform only isolate stem cells?
  • Our platform isolates stem cells along with many other types of regenerative cells. Regenerative cells are cell types that naturally promote tissue regeneration and homeostasis by facilitating the generation of new cells to replace old or injured cells in a particular tissue. Regenerative cells include several types of stem cells, progenitor cells, macrophages, and several other cell types that promote tissue regeneration and healing. These cells work together by responding to inputs from their surrounding through a complex system of signaling, resulting in synergistic healing effects that are greater than the effect that any one cell type can have on its own.
Is the Transpose® RT platform FDA approved?
  • The Transpose® RT platform is being investigated in several FDA-approved clinical trials for premarket approval (PMA) and is currently available in the U.S. for research use only. More information on InGeneron’s actively enrolling clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.
  • In the U.S., InGeneron’s Transpose® RT platform is for investigational use only. In Europe, the Transpose® RT platform uses clinical-grade components and is registered under the CE mark for human use upon prescription by a European physician.
What are the benefits of using autologous cells vs. allogeneic cells?
  • Autologous vs Allogenic: InGeneron’s cell therapy platform utilizes a patient’s autologous regenerative cells. Autologous means the cells are taken from and reintroduced into the same patient. Using autologous cells prevents the risk of transplant rejection reactions that can be associated with allogenic cell therapies, which typically utilize donor cells that have been cultured in a lab.

Reimbursement

Will this cell therapy be covered by insurance?
  • Currently InGeneron’s Transpose® RT platform is being evaluated in several clinical trials and is not eligible for insurance coverage prior to FDA approval.
  • The American Medical Association’s (AMA) Current Procedural Terminology (CPT®) Editorial Panel has issued two new Category III CPT® codes for the company’s autologous, adipose-derived regenerative cell (ADRC) therapy for partial thickness rotator cuff tears. The newly published codes (0717T, 0718T) went into effect on July 1, 2022, and mark an important step for future reimbursement of InGeneron’s cell therapy platform.
  • The newly issued CPT® codes could potentially allow for reimbursement pending future FDA approval.
    Upon market approval, InGeneron will continue to work toward converting the Category III codes to Category I to secure widespread coverage by payors and access for patients.