Protein Rich Optimized Cells (PROC)

PROC is an innovative and promising approach in regenerative medicine. It is defined as Protein Rich Optimized Cells – Optimal Purity. Our cellular program is based on a strong foundation developed by embarking on modern technology through scientific research and development. We follow a proprietary process technology with qualified staff and stringent quality control protocols optimizing the cells from patient’s own blood. The high concentrate of protein is enriched with platelets, the source of healing proteins and growth factors, cytokines, chemokines, and fibrin, the wound healing matrix that synergistically orchestrate the recruitment of stem cells. This process is designed to support the natural regeneration capability of the body’s own healing capacity needed for cellular efficacy.  This helps generate body’s own healing capacity needed for cellular efficacy.

The CelluGen ISO certified laboratory is compliant with Good Manufacturing Practice (cGMP), Good Laboratory Practice (cGLP), Good Clinical Practice (cGCP) and Good Tissue Practice (GTP).

The high quality aspect of each product is confirmed with the accompanying COA. This is giving the treating doctor and patient alike a peace of mind that the quality product produced is tested for its safety and efficacy.

Unique Processing and Characteristic of PROC / PRP Forte

  • Laboratory Clean Room Facility and Guidelines: CelluGen clean room laboratory with controlled centrifugation proprietary processes technology with qualified staff and stringent quality control protocols.
  • Processing Facility: Processing, activation and injection preparation is performed in clean room conditions environment (class 100 to class 1000).
  • Infectious Disease Screening: The peripheral blood sample drawn from the patient is screened for rapid infectious disease screening including Anti HIV (TRI DOT), Anti HBc and Anti HCV. The Infectious diseases screening are done to doubly make sure the patient is sero negative for these common infectious diseases.
  • Imported Equipment for Separation: After blood is taken from the patient’s vein, the platelet is separated from whole blood using imported specially designed equipment with controlled speed and temperature centrifuge under highly sterile conditions in Bio safety cabinet.
  • Platelet count 5-8 X from baseline
  • The pH is greater than 6.2 and lies within international guideline range between 6.2 – 7.4 aiding in higher platelet aggregation and recovery
  • Low Leukocytes count helps in optimal efficacy and reduction in inflammation (contributes to inflammatory cytokine production).
  • Low RBC count to ensure high purity
  • Inclusion of enriched injectable Fibrin – a wound healing matrix with pre existing stem cells (the generators of our body’s own healing). This results in formation of new fibroblasts, collagen and elastin tissues.
  • Screening of infectious diseases including Anti HIV (TRI DOT), Anti HBc and Anti HCV done prior to dispatch
  • The peripheral blood drawn from the patient is checked for complete differential blood count pre and post processing with emphasize on platelets count.
  • The Certificate of Analysis (COA) provided with release for therapeutic application includes pre and post processing evaluation of:
  • Platelet Count
  • WBC Count
  • RBC Count
  • Hematocrit count
  • Mean Platelet value

Collection

Peripheral blood collection done in ACD-A vacutainer

Blood collection is done from the clinic previous evening.

Delivery to the clinic is done at the time of the application for autologous use.

Factual Information:

  • Cellular based procedures should be carried under aseptic conditions in GMP and GLP facility
  • Incubation of whole blood improve the quality of Platelet concentrate before PRP preparation1
  • PROC / PRP to be injected within 4 hours of preperation2
  • Excess leukocytes in PRP contribute to deleterious effect3
  • Higher platelet concentration gradient and higher recovery result in release of larger number of growth factors, cytokines, and chemokines, needed for cellular efficacy.

References:

  • Platelet -Rich Plasma Method. Azza S, El- Danasoury, Mahira . The Egyptian Society Of Hematology.
  • Role of Platelet Rich Plasma in chronic tennis elbow. Dr. Hari Menon , National journal of clinical orthopedics.
  • Platelet Rich Plasma : The PAW classification system. The journal of Arthroscopic & Related surgery.


  • Therapeutic Effects

    • It is a concentration of the 7 fundamental protein growth factors that are actively secreted by platelets.
    • It includes 3 proteins in blood known to act as cell adhesion molecules: fibrin, fibronectin and vitronectin.
    • It promotes healing and rapid soft and hard tissue regeneration by delivering growth factors at high concentrations to the treated site.
    • Platelet Growth Factors: At the time of activation, platelets release growth factors and other molecules stored in their granules, and these are part of the natural healing process. These growth factors are regeneration-promoting signaling molecules, such as PDGF, TGF, EGF, VEGF, FGF and others. All these molecules regulate the healing process, inflammation, cell proliferation, reepithelialization, angiogenesis and tissue remodeling processes.

    Biological Actions

    • Osteoblast replication
    • Endothelial cell endothelial cell-replication
    • Fibroblast and osteoblast-replication to produce collagen, replication to produce collagen
    • Enhance bone-regeneration
    • Stimulate matrix-formation
    • Stimulation of pericytes
    • Heamostatic sealant
    • Stem cell binding
    • Growth factor concentration

    Bioactive Components

    It contains a variety of Growth Factors. These are small molecules also known as cytokines that interact with the local cells and even send signals that initiate a variety of important events such as cell division and migration.

    • Platelet-derived growth factor
    • Transforming growth factor beta
    • Fibroblast growth factor
    • Insulin-like growth factor 1
    • Insulin-like growth factor 2
    • Vascular endothelial growth factor
    • Epidermal growth factor
    • Interleukin 8
    • Keratinocyte growth factor
    • Connective tissue growth factor

    Cellular Components

    Platelets are known for their importance in clotting blood. However, platelets also contain many proteins known as growth factors which play significant role in the healing of injuries.

    Growth Factors are generally considered as a subset of cytokines, refer to the diffusible signaling proteins that stimulate cell growth, differentiation, survival, inflammation, and tissue repair. They can be secreted by neighboring cells, distant tissues and glands.

    Cytokines are a broad category of proteins responsible for sending signals to the molecules that aid cell to cell communication in immune responses and thus stimulate the movement of cells towards sites of inflammation, infection and trauma. Cells upon activation further produce more cytokines.

    Chemokines are signaling proteins with ability to induce directed chemotaxis in nearby responsive cells.

    Arthritis and PROC/PRP Program

    Osteoarthritis (OA) is a degenerative chronic condition of the joints when the cartilage that cushions the joints starts breaking and wears away. It is known to affect any joint, but occurrence is more often in knees, lower back and neck, hips, small joints of the fingers and the bases of the thumb and big toe.

    Arthritis is the most prevalent joint disease and a frequent cause of joint pain, functional loss, and disability, and conventional treatments other than surgeries have demonstrated only modest clinical benefits without lesion reversal. Cell-based therapies have shown encouraging results in both animal studies and a few human case reports. Most cellular research focuses on the use of protein rich plasma and stem cells. The systematic research showed an increasing number of published studies on this topic over time, clinical trial data with preliminary interesting findings are available

    What is the concept?

    PROC / PRP therapy helps in regeneration of bone and cartilage along with activated PRP based biopolymer which holds stem cells at the site of lesion and provide medium and nourishment to the other cells so that they can work better together.

    What to expect?

    There are various medical references to share that the platelet-rich plasma might:

    • Inhibit inflammation and slow down the progression of osteoarthritis1
    • Stimulate the formation of new cartilage2
    • Increase the production of natural lubricating fluid in the joint, thereby easing painful joint friction3
    • Contain proteins that alter a patient’s pain receptors and reduce pain sensation4,5

    References:

    1. Van Buul GM, Koevoet WLM, Kops N, et al. Platelet-rich plasma relea- sate inhibits inflammatory processes in osteoarthritic chondrocytes. Am J Sports Med. 2011;39:2362–2370.
    2. Drengk A, Zapf A, Sturmer EK, et al. Influence of platelet-rich plasma on chondrogenic differentiation and proliferation of chondrocytes and mes- enchymal stem cells. Cells Tissues Organs. 2009;189:317–326.
    3. Anitua E, Sanchez M, Nurden AT, et al. Platelet-released growth factors enhance the secretion of hyaluronic acid and induce hepatocyte growth factor production by synovial fibroblasts from arthritic patients. Rheuma- tology (Oxford). 2007;46:1769–1772.
    4. Descalzi F, Ulivi V, Cancedda R, Piscitelli F, Luongo L, Guida F, Gatta L, Maione S, Di Marzo V. Platelet-rich plasma exerts antinociceptive activity by a peripheral endocannabinoid-related mechanism. Tissue Eng Part A. 2013 Oct;19(19-20):2120-9. doi: 10.1089/ten.TEA.2012.0557. Epub 2013 Jun 6. PubMed PMID: 23578218.
    5. The International Cellular Medical Society. Guidelines for the Use of Platelet Rich Plasma. Adopted 2011.cellmedicinesociety.org. Accessed August 15, 2013.

    Who can participate in the program?

    Patients with Arthritis of the Joints like Knees, Hip, Shoulder and Ankle or Avascular necrosis of femoral head (AVN) as selected by our treating physicians. It is important for the patient to share the latest reports of the joint(s) and present health condition along with the medication being used so as to help the doctor to review the case completely and clinically evaluate the case for the suitability of the said program.

    Procedure

    This program consists of Autologous PROC/PRP procedure as per your condition.

    Duration of program is of two days as a day care program, there may be minor variations which would be intimated to you as and when needed.

    Our specialized day care program is split into two days as per the details mentioned below:

    This specialized program is as given below:

    Duration: Two half days (day care)

    Day one: These therapies are combination of detoxification as well as boosting and optimizing the cells.

    Hyperbaric Oxygen Therapy (HBOT): it is the medical use of oxygen in a high pressure oxygen therapy chamber, at a level higher than 1 atmosphere absolute (ATA). Increased pressure allows oxygen to diffuse and saturate more effectively in the blood system, primarily the plasma (independent of hemoglobin), which yields a broad variety of positive physiological, biochemical and cellular effects. HBOT is the most trusted non-invasive therapy to increase oxygen levels to all the organs.

    OR

    Ozone Breathing: Oxygen is present in the air is a pair of oxygen atoms but Ozone is composed of three oxygen atoms instead of two. Presence of third Oxygen atom makes it supercharged oxygen and gives it all its medical properties. Medical ozone therapy is a distinctive treatment when Oxygen is passed to all the blood cells through breathing and beneficial for full body stimulation as well as a removal of free radicals that help in detoxification and healing of the body.

    IV Therapy: Immuno Boost: Stimulates and enhances the function of the immune system. It encourages cellular repair, regeneration of cells, and speed-up the recovery process.  It improves nutritional deficiencies thus elevating the sense of wellbeing.

    Coffee Enema: Cleans the waste and toxins from your body further boosts immunity, stimulate the intestines and increases energy. It is a great way to detox the system.

    Magnesium Sulphate Detox: Helps in Blood Circulation and remove the accumulated heavy metals and toxins from your body

    Collection of your whole blood is done and is sent to the lab for overnight incubation. As per the scientific studies it improves the quality of protein concentrate before preparation.

    Day two: The infusion/infiltration is done at the joint through C-arm guided procedure in minor OT by the treating orthopedic specialist depending on your case.

    Post Procedure Care: Following procedure, it is usually suggested by your trating Orthopedic Specialist that you reduce any major activity for up to one week. Required daily activities are encouraged but exercises are suggested to be avoided. There may be moderate discomfort or increase in pain at the site of infusion/infiltration for few hours or days for which appropriate pain relief treatment/medication will be suggested by the treating doctor.

    Contraindications:

    • Sepsis
    • People on anti-coagulation treatment
    • Autoimmune conditions
    • Active malignancy
    • Infection or local skin damage
    • Suffered any type of cancer
    • Have certain implants in the treatment area.
    • Past and present medical history along with past cosmetic history will also determine the suitability.
    • Pregnant and Breast-feeding ladies
    • People with high blood sugar levels
    • Diabetic patients will have to go for a second opinion from Diabetologist