Viyata Ultra(The Complete GFC kit)
How To Prepare Viyata GFC?
Step 1: Collected 8ml Blood in 1 vacutainer provided in kit with Blood collection set provided in kit.
Step 2: Mix Collected *ml Blood By inverting Vacutainer 6 to 7 times and keep it a Side in upright position for 30 min for Platelet activation Process.
Step 3: Centrifuge Vacutainer with proper counter balancing at 3400RPM for 10Min
Step 4: Collect 3.5 to 4ml GFC Serum from tube and inject at side of action
What is GFC Therapy?
GFC stands for Growth Factor Concentrate which is a pure, highly safe, highly concentrated growth factor preparation concocted from patient’s own blood for superior results.
Various growth factors are stored in our platelets. Flowrich’s scientists have been able
to extract these growth factors at high concentration as a Growth Factor Concentrate
(GFC) in specially designed Viyata GFC Kits. This GFC is administered at the site of requirement as per indications, thus, bringing patients own growth factors at high concentration right at the intended site.
Why GFC Therapy?
GFC Therapy is latest therapy. It is an innovative therapy, researched and concocted by Flowrich’s Regenerative Medicine Department.
Rather than giving platelets, GFC therapy provide high concentration of patient’s
Growth Factors extracted from platelets, which are actual agonist in tissue regeneration & repair. Flowrich’s proprietary platelet activator is used in specialized kits, to release various growth factors from α Granule of platelets into GFC. Platelets are activated prior to centrifugation (in Vitro/ ex vivo), thus ensuring no platelet loss & release of all GFs from α Granules.
Role of GFC in orthopedics
Tendinopathy and osteoarthritis are common chronic musculoskeletal conditions that are associated with frequent pain and reduced function. With the discovery of autologous Growth factor concentrate (GFC) therapy, new opportunities are available to elucidate potential healing mechanisms and elaborate safe injection therapies. GFC therapy involves the use of autologous, high concentration of growth factors extracted from platelets activated with the help of Flowrich’s platelet activating solution. The underlying principle of GFC is to deliver a large pool of signaling proteins such as growth factors and other cytokines to the local milieu driving the tissue regeneration mechanisms.
GFC is capable of interfering with various healing mechanisms – that is, influencing the controlled inflammatory response, inducing cell migration and proliferation, and modulating angiogenesis. Given the redundancy and pleiotropy of the grow factors, the specific actions of individual growth factor and the molecular mechanisms remains to be exploited fully. GFC therapies provide a multifunctional microenvironment by a myriad of molecules involved in the healing mechanisms. They target multiple cell phenotypes and modulate various biological processes including inflammation, angiogenesis, cell migration and proliferation and the anabolism/catabolism (synthesis and remodeling) of extracellular matrix.
Related products
Platelets are cytoplasmic fragments of megakaryocytes, formed in the marrow and approximately 2cm in diameter. They contain more than 30 bioactive proteins, many of which have a fundamental role in hemostasis or tissue handling. Upon activation of platelet granules presenting platelet start to fuse to its cell membrane (also degranulation) where the secretory proteins (e.g. PDGF, TGF etc.) are transformed to a bioactive state. The active proteins are then secreted, binding to a Trans membrane receptor of target cells, which include mesenchyme stem cells. These agonist-bond Trans membrane cells and epidermal cells, osteoblasts. Fibroblasts, endothelial receptor than active an intracellular signal protein that causes the expression of gene sequence that directs cellular proliferation, matrix formation, osteoid production, collagen synthesis etc. Thus, provoking tissue repair and tissue regeneration.
The Platelet Rich Plasma (PRP), which is a concentrated blood plasma enriched with platelet is a relatively old but dynamically developing technique used in many fields of medicine. The concept and description of PRP started in the field of hematology in the 1970 in order to describe the plasma with a platelet count above that of peripheral blood, which was initially used as a transfusion product to treat patients with thrombocytopenia. Later it becomes popular maxillofacial surgery (1980), sport injuries (1990). Cosmetology (2000 onward). Other medical fields that also use PRP are cardiac surgery, pediatric surgery, gynecology, and urology. Plastic ophthalmology surgery.
There is an intense ongoing debate regarding the ideal volume of PRP to be administrated, the frequency of application, the exact site of administration, of PRP, and which technique /preparation system of manufacture to use. Even though most devices aim to obtain the best PRP, the system differs extensively in their ability to collect and concentrate platelet depending on the method and time of its centrifugation. There is no consensus about the number of centrifugation required, nor on their speed and duration.
Different PRP preparation protocols may result in varying platelet concentration, and thus difference biologic effect may occur.
The platelet count is the key that decide to regenerative capacity of PRP. In addition qualitative alteration during process in the platelet may also affect the regenerative potential of PRP. According to Marx, platelet damaged or rendered non-viable by the protocol used to process the PRP will not secrete bioactive growth factor. Thus the resulting outcome may be disappointing.
Thus, disappointment of PRP therapy is attributed to therapy gap between use of platelet concentrate for treatment while actual work is done by various growth factor released upon activation of platelet. So far, researches have not been able to establish how many growth factors can be released after PRP administration and how exactly these platelets are activated once they are injected. Moreover, PRP kits do not remove RBSs and WBCs completely. This may lead to post procedural pain, inflammation and interference and tissue regeneration and healing. Also there is a variable loss of platelet during PRP preparation irrespective of technique used, which may give u high concentration but not entire quantity of platelets.
Therefore, the concept of therapy kit that would process the patient blood in such a way that there will be no platelet loss and final output will have high concentration of growth factor extracted from platelets without the presence of any unwanted RBS and WBC’s was perused
Platelets and their growth factors
Platelets are the smallest of the three major types of blood cells. The normal platelet count is about 150,000- 350,000 per microliter of blood. The principal function of platelet is to prevent bleeding. Platelets are produced in the bone marrow from very large cells called megakaryocyte. The contain granules that can secrete proteins required for creating a firm plug to scal blood vessel breaks. Platelets are shaped like a plate, therefore the name. When platelet is stimulated by a break in the blood vessel wall, they change shape. Once, activated, platelet causes degranulation of the- granules that contain various growth factors believed to be important to perform various action. The active proteins secrete bind to transmembrane receptor of target cells, which include mesenchymal stem cells, osteoblasts, fibroblasts, endothelial cells and epidermal cells. These agonist-bound transmembrane receptor than active an intracellular signal protein that causes the expression of a gene sequence that direct cellular proliferation. Matrix formation, osteoid production, collagen synthesis, etc. thus provoking tissue repair and tissue regeneration
Growth Factors
Important growth factors released after activation of platelets are depicted as below:
PLATELATS-RICH-PLASMA (PRP)
The concept and description of PRP started originally in the field of hematology but later, the scope of its use increased extensively. Other medical fields that also use PRP are cardiac surgery, pediatric surgery, gynecology, urology, plastic surgery, orthopedics and ophthalmology.
• PRP is a biological product defined as a portion ofthe plasma fraction of autologous blood with a platelet concentration above the baseline (before centrifugation).
• Marx proposed that platelet count of 10Lakh/ml in S ml of PRP. as a working definition of PRO.
• The mean concentration of platelet in blood is 200,000-75.000 for a preparation to be labeled as PLATELET-RICH; the concentration of platelet should rise to level of five of ten times the base line.
• Nowadays in the market. Various automated devices are available for preparing PRP with variable output and various techniques
Steps for PRP preparation
1. Obtain whole blood by performing venepuncture using vacutainer tubes with an anticoagulant such as citrate dextrose A.
2. Centrifuge the tube under a soft speed (‘soft or light- spin’ centrifugation).
The sample should separate into
a. A yellow top layer (plasma) b. a thin middle layer-the buffy coat (platelets and white blood cells) – and c. cared bottom layer (RBCS) Aim is to separate the plasma from rest of the components
3. For the production of pure PRP, the upper layer and superficial buffy coat should be transferred to an empty sterile tube. For the production of L-PRP, the whole buffy coat layer and a fraction of the RBCs should be transferred.
4. Spin a second time ‘hard’ or heavy-spin centrifugation is faster so that platelets get concentrated and settle down at the bottom of the test tube as “pellet”
5. Remove the upper 2/3 of fluid from the tube.
6. Homogenize the pellet in the remaining 1/3 of fluid. This is ready to use PRP
7. In some cases, an activator is added to the platelet enriched product. Calcium chloride (CaCl2) or thrombin isthen added as an activator to activate the platelets and hence degranulation of GFs to yield ‘activated PRP”
• There is variability in the yield of platelets obtained depending upon the methods used, rate and time of spin, anticoagulant used and even the size and shape of container.
• The platelet yields may vary from 4 to 7 times the baseline. To assure the viability of platelets the temperature should be maintained between 20-22 degree centigrade.
• Double spin method is used preferably over single spin method, as studies have shown that the single spin method failed to achieve the therapeutic levels of platelet. However, with double spin, alterations in platelet morphology is been reported.
• As there are different protocols, devices and centrifuge speeds for preparing PRP. Different types of platelet concentrates are obtained.
• In 2016, Magaion et al. proposed the DEPA classification (Dose Efficiency. Purity. Activation) that focusses on the quantity of platelet obtained by the PRP kits as well as on product purity and on platelet activation prior to injection various kits produce variable platelet concentration, because of technique and loss of platelet in process, and presence of impurities such as unwanted RBCs and WBCs.
Drawbacks with PRP kit
Why PRP does not have optimal therapeutic response is that the concentration of
platelets in the PRP obtained is low, probably because up to 35% of platelets are
lost during processing.
Platelets obtained from most of the PRP are in inactivated form & requires
activation to release GFs. So, after injection of PRP in scalp, it requires activation
to release GFs at the site of injection. Till date, researchers are not able to explain
after injection of platelet:
• How exactly platelets are activated?
• How many platelets are activated?
• How many Growth factors are released?
For functional PRP, the platelets need to be activated by addition of platelet
activator. This process is usually not simple & requires multiple step procedure,
which may hamper the sterility of procedure & may expose the PRP to external
environment & contamination.
• For platelet activation, usually bovine thrombin is used which may cause
immune reaction and also carries a threat of transmission of bovine viruses
or diseases to humans. The use of human thrombin makes the product
uncommercial due to its high cost.
• Presence of bovine thrombin (platelet activator originating from cow, bull)
raises a safety concern
• PRP contains not only a high level of platelets, but also WBCS which are
simultaneously concentrated in the platelet fraction. Presence of WBC’s and
RBCs are detrimental to the healing effects. Most commercially available PRP
preparation kits do not remove RBC’s and WBC’s
• Presence of WBCs will have inflammatory components which may increase
pain, tissue damage and inflammation post-treatment.
• Since, preparation of PRP required lot of manoeuvring. like extraction of
buffy coat, extraction of PPP etc. there are high chances of variation in PRP
output and eventually its therapeutic benefit.
What is GFC therapy?
GFC stands for Growth Factor Concentrate which is a pure, highly safe, highly concentrated growth factor preparation concocted from patient’s own blood for superior results. Various growth factors are stored in our platelets. Flowrich’s scientists have been able to extract these growth factors at high concentration as a Growth Factor Concentrate (GFC) in specially designed Viyata GFC Kits. This GFC is administered at the site of requirement as per indications, thus, bringing patients own growth factors at high concentration right at the intended site.
Why GFC Therapy?
GFC Therapy is latest therapy. It is an innovative therapy, researched and concocted by
Flowrich’s Regenerative Medicine Department.
Rather than giving platelets, GFC therapy provide high concentration of patient’s
Growth Factors extracted from platelets, which are actual agonist in tissue regeneration
& repair. Flowrich’s proprietary platelet activator is used in specialized kits, to release
various growth factors from α Granule of platelets into GFC. Platelets are activated
prior to centrifugation (in Vitro/ ex vivo), thus ensuring no platelet loss & release of all
GFs from α Granules.
How GFC is different from PRP?
How To Prepare Viyata GFC?a
Step 1:- Collected 8ml Blood in 1 vacutainer provided in kit with Blood collection
set provided in kit.
Step 2 :- Mix Collected *ml Blood By inverting Vacutainer 6 to 7 times and keep
it a Side in upright position for 30 min for Platelet activation Process.
Step 3 :- Centrifuge Vacutainer with proper counter balancing at 3400RPM for
10Min
Step 4 :- Collect 3.5 to 4ml GFC Serum from tube and inject at side of action.
Role of GFC in orthopedics
Tendinopathy and osteoarthritis are common chronic musculoskeletal conditions that are associated with frequent pain and reduced function. With the discovery of autologous Growth factor concentrate (GFC) therapy, new opportunities are available to elucidate potential healing mechanisms and elaborate safe injection therapies.
GFC therapy involves the use of autologous, high concentration of growth factors extracted from platelets activated with the help of Flowrich’s platelet activating solution. The underlying principle of GFC is to deliver a large pool of signaling proteins such as growth factors and other cytokines to the local milieu driving the tissue regeneration mechanisms.
GFC is capable of interfering with various healing mechanisms – that is, influencing the controlled inflammatory response, inducing cell migration and proliferation, and modulating angiogenesis. Given the redundancy and pleiotropy of the grow factors, the specific actions of individual growth factor and the molecular mechanisms remains to be exploited fully. GFC therapies provide a multifunctional microenvironment by a myriad of molecules involved in the healing mechanisms. They target multiple cell phenotypes and modulate various biological processes including inflammation, angiogenesis, cell migration and proliferation and the anabolism/catabolism (synthesis and remodeling) of extracellular matrix. Possible links between GFC and chronic musculoskeletal conditions is shown in figure 1
Application GFC in orthopedics
Osteoarthritis
Osteoarthritis is a degenerative disease of synovial joints resulting in the progressive loss of articular cartilage. The etiology can be primary (intrinsic defect) or secondary (trauma, infection). It starts with a loss of the weight-bearing articular cartilage surface followed by osteophyte development. Late disease is characterized by cartilage disintegration exposing the bony surface. Biochemically, there is an alteration in proteoglycans (decreased content and increased chondroitin/keratin sulphate ratio). There is also an increase in metalloproteinases and IL-1 which may have a catabolic effect leading to cartilage degeneration. Histologically, there is a loss of superficial chondrocytes, breakdown of the tidemark, and fissuring and cartilage destruction with eburnation of subchondral bone. Normal cartilage is a vascular which accounts for its lack of inherent healing potential. Radiographic findings include subchondral cysts/ sclerosis, marginal osteophyte formation and joint-space narrowing and by acting as an osmotic buffer. Osteoarthritis (OA) has unique characteristics with respect to joint biology, homeostasis, and levels of metalloproteases and inflammatory cytokines, contributing to patient symptoms.
There has been increased interest in the regenerative medicine for intraarticular injections for nonsurgical management of osteoarthritis of the knee. When GFC is injected into the injured site various growth factors like platelet-derived growth factor (PDGF), interleukin-1 receptor antagonist (IL-1RA), soluble receptor of tumor necrosis factor α (TNF-αR), transforming growth factor β(TGF- β), platelet factor 4 (PF4), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor (IGF), osteocalcin (Oc), osteonectin (On), fibrinogen, vitronectin, fibronectin and thrombospondin-1 (TSP-1) are available for action. Chondrocytes stimulated with growth factors extracted from platelets increase proteoglycan and collagen synthesis which have similar histological and biochemical qualities to normal hyaline cartilage. Many of these mediators present in GFC act as anti-catabolic and anti-inflammatory agents. The antagonist of IL-1 receptor inhibits activation of NF β gene, cytokine involved in apoptosis and inflammation process. Moreover, the soluble receptors of the tumor necrosis factor bind to TNF-α, preventing its interaction with cellular receptors and its pro-inflammatory signaling. TGF-β1 also acts as a factor inhibiting cartilage degradation, regulating and enhancing gene expression of tissue inhibitors of metalloproteinases (TIMP-1). Other factors such as IGF-1, PDGF and TGF- β1 favor the stabilization of cartilage by controlling the metabolic functions of chondrocytes andsubchondral bone, maintaining the homeostasis between the synthesis and degradation of proteoglycans, and stimulating the proliferation of chondrocytes. It was also found that platelet growth factors stimulate synovial fibroblasts to synthesize hyaluronic acid.
TNFα, tumor necrosis factor α; TNF α R, tumor necrosis factor α receptor; IL-1 interleukin-1; IL-1R, interleukin-1 receptor; TGF β, transforming growth factor β; TIMP, tissue inhibitor of metalloproteinases; PDGF, platelet-derived growth factor; IGF, insulin-like growth factor; FGF-2, fibroblast growth factor-2
Tendinopathy
The term tendinopathy is used to describe the clinical syndrome characterized by a combination of longstanding activity-related pain, swelling (diffuse or localized) and impaired performance. Mostly mechanical overwork & in addition to it, chemical or physical stresses can provoke an abnormal healing response, which brings forth biochemical changes in the microenvironment. These include overexpression 15 of inflammatory mediators that along with degradation products initiate the pathological cascade leading to tendinopathy. Eventually, several factors may enhance the vulnerability to tendinopathy, for example extrinsic (i.e., heavy sport activities, environmental adverse conditions and training errors) and intrinsic factors (i.e., advanced age, osteoarticular pathologies and systemic diseases affecting microcirculation or collagen metabolism), as well as genetic susceptibility.
The treatment of tendon injuries or tendinopathies with GFC is an evolving therapy. Many of the growth factors in GFC are involved in the signaling pathways that occur during healing stages of inflammation, cellular proliferation, and subsequent tissue remodeling. GFC may also promote neovascularization, which may increase the blood supply and nutrients needed for cells to regenerate the injured tissue as well as bring new cells and remove debris from damaged tissue. These mechanisms of action may be particularly relevant in chronic tendinopathies, where the biologic conditions are unfavorable for tissue healing.
• Lateral Epicondylitis
• Patellar Tendinopathy
• Achilles Tendinopathy
• Rotator Cuff Tendinopathy
• Plantar Fasciitis
Potential Role of Growth Factors in other orthopedic conditions
• Fracture and Non-union Management
• Rotator Cuff Repair
• Achilles Tendon Repair
• Ankle Sprains
• Muscle Injuries
• Anterior cruciate ligament reconstruction
What are the advantages of Viyata GFC Therapy?
1 No platelet loss and high concentration of growth factors
• Viyata GFC therapy process blood such that almost all the platelet is activated prior to centrifugation with the help of Flowrich Pharma Pvt. Ltd. platelet-activator solution present in the tubes. therefore, no platelet loss can happen.
• Subsequent centrifugation allows growth factor like PDGF, VEGF, EGF, IGF, FGF, KGF, TGF, to get concentrated in supernatant in very high concertation.
2 Completely acellular and reduce risk of pain and inflammation.
• GFC is collected is acellular. It contains high concentration of GFs and no cells like RBCs or WBCs.
• It eliminates red blood cells (RBCs) which show no therapeutic effect for regeneration & may create a more viscous solution which can be more painful when inject.
• It eliminates WBCs, which are pro-inflammatory and may increase pain. tissue damage and inflammation post treatment.
3 Excellent stability
• Once prepared Viyata GFC concentrate can remain stable for about 8hrs at room temperature & in refrigerator at 4°C for a week.
4 Safe option
• Since, it is made from the patient’s own blood (autologous therapy), there are no chances of immunological reaction and is hence considered as one of safest option for treatment.
5 No risk of contamination
• No separate platelet activator is required to be added from outside to active platelet and released their growth factors. This ensures a closed environment for GFC preparation and thus minimizes the risk of contamination
6 Simple procedure and no operator-dependent variation
• No changing of tubes. No transferring of blood components.
• No addition of activators from one tube to other and only one-time centrifugation is required
• No operator-dependent variation in growth factor output. Preparation of CFC takes about 40 mins.
7 Desired results
• High concentration of Growth factor concentrate provides desire effects
Performance data of GFC output
1. A cellularity
• GFC output is an acellular solution containing high concentration of growth factors and it does not contain any cells like RBC, or WBC,
2. Sterility
• The Viyata GFC therapy kit, being a closed system and the sample not being subjected to the external environment, the resulting growth factor output is sterility. Sterility was tested by using Nutrient and Saborauds Agar. Performance data of GFC output 18
3. Stability
• Stability of GFC output is shown below
4. Colour
• Normal colour of final GFC output can range from yellow-yellowish, brownorange to reddish. However, colour range has no effect on quantity and viability of growth factors.
5. Possible side-effect
• Since GFC is an acellular therapy. It does not contain any RBC or WBC, and hence the risk of pain and inflammation because of GFC itself is minimal.
• Because GFC therapy involves injecting autologous GFC into the scalp, there is no risk of getting a communicable disease.
• However, any treatment that involves injection carries a risk of side-effect such as injection site pain, injury to blood vessels or nerves, infection, scar tissue.
6. Possible consequences/precautions
• There is no activity restriction after a GFC therapy. Patients may shower/ shampoo/ condition their hair normally justseveral hours afterthe treatment and resume normal daily and athletic activities. • Some brief mild inflammation is noticeable and redness/pinkness and numbness of the scalp may be present of several hours.
7. Caution
• Caution has to be exercised and risk verses benefits to the patient need to be assessed before starting the GFC therapy in patient with active scalp infection, bleeding disorders blood dyscrasias or hemoglobinopathy. autoimmune disorders, count, prior hypersensitivity reaction to therapy and immunosuppressant immune-modulators. taking
8. Use in specific populations
• The safety and effectiveness of GFC therapy in pediatric population, pregnancy and nursing mothers have not been established.
9. Shelf life
• Expiry of Viyata GFC therapy kit is, mentioned on back of box
10. Storage and handling
• Do not use GFC therapy kit after the expiration date. Store the Flowrich GFC therapy kit at room temperature
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