Disclaimer: This document is intended exclusively for RGCC practitioners as an informational resource and guide to support the understanding and application of therapy protocols. It is not intended for use as medical advice for patients, nor should it be shared directly with patients or used as a substitute for individualized patient care. Please assess each patient’s unique health needs and circumstances independently.
Unauthorized distribution to patients is prohibited and can result in immediate disciplinary action including, but not limited to, dismissal from the RGCC network.
General Info
Brief Description
Q-REstrain is an autologoustherapy which is based on RNA Interference technology. RGCC’s lab can identify the specific gene sequence of different targets such as cancer cells, Lyme, and various viruses and take advantage of oligonucleotide molecules (microRNAs isolated by patient’s sample), which contribute to gene silencing of these specific genes.
Way of Function
A patient’s blood is sent to RGCC, and they identify the appropriate gene that need to be silenced. Once they detect the potential genes for targeting, they validate these targets both in silico and in vitro. The validation of target ensures the highest specificity and that Q-REstrain do not interfere with any other targets. Once the different target genes have been validated, then the most appropriate is selected. Oligonucleotides, with RNAi capabilities, such as microRNAs, complementary to the mRNA for a specific region of this gene are then used The final goal is to inhibit the expression of proteins which are essential for cells metabolism and/or survival.
Inclusion – Exclusion Criteria
Eligibility Criteria
Cancer patients with either solid tumor, or hematological malignancies, independent of stage of the disease. However, patients with large tumor burden in highly vasculated tissue (eg lung) are at risk for tumor lysis syndrome
Patients infected by different viruses (HSV, VZV, EBV, HPV, HBV, HCV, HIV, Coxsackie, etc.)
Patients with Lyme Disease (infected by Borrelia, Bartonella, Babesia strains)
Patients infected by Anaplasma, Rickettsia, Ehrlichia strains
*Please see our complete list for further info on the appendix
Exclusion Criteria
Cancer patients with CNS cancer
Cancer patients < 11 years old
Patients < 5 years old infected by different viruses or other strains
Patients under Gamma Delta T Cell Therapy (GDTC)
Patients under treatment with Radioactive Seeds
Contraindications/disqualifications
Pregnancy or breastfeeding – must wait 6 months
Recent blood transfusion – must wait 120 days
Recent cytotoxic chemotherapy and/or radiotherapy – must wait 14-21 days
Radioactive Seed Therapy (permanent contraindication for Cancer only)
Delta T. Cell Therapy (GDTC) (permanent contraindication for Cancer only)
Children under the age of 11 for cancer
Children under the age of 5 for viral or Lyme
Pre-requirements
Cancer (Apoptosis Inducer)
The patient must be off cytotoxic therapies and free radical producing substances 7-21 days prior to the blood draw for the Q- REstrain and again 7-21 days prior to the actual administration of the Q-REstrain therapy. Some therapies require a longer time frame. See below for details.
Blood Transfusions: at least 120 days
CDK Inhibitors: for at least 14 days
Chelation Therapy (IV): Avoid at least 14 days
Chemotherapy (non-platinum derivative): at least 14 days
Chemotherapy (platinum derivative): at least 21 days
Cryoablation: at least 7 days
Fever: at least 14 days
Gamma Delta T Cell Therapy (GDTC): Patients are not eligible for therapies due to the potential interaction with RGCC therapies.
Hormone suppression: at least 14 days (½ life x 7 is ideal formula for avoidance)
Hyperbaric Therapy: at least 7 days
Hyperthermia (generalized/systemic): no waiting
Hyperthermia (local/concentrated/microwave ablation): at least 30 days due to increased cellular debris released into the bloodstream
Immune Suppression Medication: at least 14 days
Methylene Blue: at least 14 days
Mistletoe: Avoid for at least 21 days
MOAB or SMW drugs: for at least 14 days
Natural Substances (IV): cytotoxic substances like Vitamin C or Ozone at least 14 days.
Natural Substances (oral supplements): Class 1 or 3 cytotoxic substances (per patient’s Onconomics Plus results) at least 14 days.
NK1 Inhibitors: for at least 14 days
NSAIDS: Do not have to be discontinued
Off Label Medications: Ivermectin-FenBen-Itraconazole: 14 days
Off Label medication: Doxycycline: 7 days
Off Label Medication: Metformin: 21 days
PEMF Therapy: at least 7 days
Plasmapheresis: Potential risk but not studied. Use your own discretion.
Radiation: at least 14 days
Radioactive Seeds: Patients are not eligible for therapies due to the prolonged and undetermined time of the radiation exposure
Scans with Contrast: at least 14 days
Surgery (brain or extensive): minimum of 30 days based on time of recovery. Could be longer if slow recovery or if the person had some type of adverse reaction. Must be evaluated on a case-by-case basis.
Surgery (simple/routine): at least 7-10 days
Virus/Lyme (Antagonist)
The patient must be off all therapies for 14 days prior to the blood draw for the Q-REstrain and again 14 days prior to the actual administration of the Q-REstrain therapy. This includes:
Antibiotics (oral or IV)
Antiviral medications (oral or IV)
Anti-parasitic medications (oral or IV)
Methylene Blue
Rife (if targeting pathogens)
Scan with contrast
Vitamin C (IV)
Colloidal Silver (oral or IV)
H2O2 IV
Ozone (IV)
Natural Substances (ALL oral supplements that are trying to kill or suppress the same target as the Q-REstrain)
Pre-Test Requirements- Cancer
Positive test results confirming presence of CTCs (Oncotrace, Oncotrail or Oncocount)
Test result must be within six (6) months (date of blood draw)
Pathology results will not be accepted
Pre-Test Requirements Viral/Lyme
Positive test result confirming presence of the targeted pathogen
Test result can be PCR or antibody result
Test result must be serum-based results (urine are not accepted)
Pathology results will not be accepted
IND or NPS will be accepted but these results run a higher risk of the pathogen not being found and a cancellation fee being incurred.
Test result must be within six (6) months (date of blood draw)
Test must be from a reputable lab
The purpose of the blood draw guidelines is to ensure the highest level of accuracy of the targeting by removing treatments and/or substances that may interfere with this. The average patient is on a multitude of substances so often it’s best to just cease all potentially interfering substances prior to the blood draw. However, if a patient is unwilling or unable to cease all substances, then the physician or the patient themselves will have to decide what is the most likely substance to interfere with the test results
Ordering/Manufacturing
Blood-Draw
15-30ml whole blood in RGCC vials (1 glass vial) is enough for 1 to 2 Q-REstrain
Order Includes
One Q-REstrain vial
Production
The production to delivery period is approximately 15 days.
The delivery shipment schedule varies from one to two weeks.
Number of Q-REstrain
Cancer - Maximum of four (4) total in a 12-month period (must be spaced at a minimum of three months apart)
Viral or Lyme - Maximum of nine (9) total in a 12-month period (must be spaced a minimum of (7) days apart)
Q-REstrain for the same target must be spaced at a minimum of (3) three months apart and you must provide updated test results that shows the pathogen is still present before a repeat for the same pathogen will be allowed.
Shipping
If multiple therapies (more than 2) are ordered for the same patient, they will not all be shipped at the same time anymore. The new policy is that a maximum of 2 therapies will be shipped at any one time for the same patient.
There will be a two-week period between each set of 2. Once again, only for the same patient.
The lab will use their best judgment to establish shipping order. Thus, if you (the practitioner) have a preferred shipment order, you will need to inform the lab which therapies they would like shipped first, second, third, etc. until all therapies have been dispatched. This is done in response to the Incoming Samples email.
Q-REstrain can be delivered only to RGCC registered clinic or physicians. Never send a Q-Restrain directly to a patient.
Storage
Q-REstrain in the dried form can be stored for up to six months if kept at room temperature and protected from light. Storage in a drawer or in a climate-controlled environment is acceptable.
Q-REstrain after reconstitution can be stored in a freezer at -17 to - 23C for up to 21 days. Longer than 21 days needs to be stored at - 80C
Preparation-Administration
Materials
NS 250 ml bag
IV Tubing
Injection Plug with Cap
22 G IV Catheter
Extension Tubing Set
(3) 3 ml syringes (one for 1 ml sterile water, two for drawing up pre- meds)
10 ml syringe Label with: Patient name, Q-REstrain therapy #)
20 ml syringes -pre-meds will be added - Label dexamethasone and famotidine)
60 ml syringe (to draw off NS waste from 250 ml bag)
10 ml NS IV Flush syringes (1 for after each pre-med and 2 for after Q-REstrain)
Upon receipt of the Q-REstrain, you will need to cross-reference the number on the Q-REstrain container to your patient’s name. There will not be a name on the actual Q-REstrain container so this is important.
Inspect immediately upon receiving. Q-REstrain is sterile, freeze dried-lyophilized synthetic oligonucleotides and can be stored at ambient room temperature and out of direct light for up to six (6) months if never opened.
The vial top should be wrapped with a sealed tamper proof tape.
The crystal/powder/gel-drop like, is very tiny and should be clear or white only. Your clinic may want to obtain a strong magnifying glass for this purpose. If the crystals are other than clear or white, do not administer the Q-REstrain, the vial has been compromised. Contact RGCC for a replacement.
The Q-REstrain is freeze dried, but do not expect a powder form. The Q-REstrain is actually closer to a tiny crystal (it can be confused with a drop sometimes) so if you see a small, clear and gel-like drop at the bottom of the vial that is normal. With a gentle swirling, the crystal should remain in the initial position, while a true humidity drop will move. Additionally, if you are not able to easily see through the vial then that is true humidity. Do not administer the Q-REstrain. Contact RGCC for a replacement.
If there are foreign bodies observed after reconstitution (wait at least 10 minutes after reconstitution, true foreign bodies will not dissolve), DO NOT administer the Q-REstrain. Contact RGCC for a replacement.
If any of the above occurs, please take a picture and email to the appropriate branch/distributor.
Preparation
Dissolve the tiny amount of powder/crystals by adding 1 ml of sterile water to the Q-REstrain vial. Do not use saline to dissolve the crystals
Close the screw cap, vortex (swirl) the vial gently until the solution becomes clear with no remaining precipitant – Do not shake or use sonication to mix
Draw 9 ml of normal saline in a 10ml syringe
Draw up the 1 ml of reconstituted Q-REstrain into the 9 ml of normal saline into the syringe
Tilt back and forth gently to mix
The Q-REstrain is now reconstituted and ready to be infused
Preparation (Half Dose)
Proceed to the steps of “preparation” and then follow the next steps
Use a marker and mark the 5 ml spot on the syringe
Administer the first half (5 ml) of the reconstituted Q-REstrain
Transfer the remaining 5 ml of reconstituted Q-REstrain solution into a cryo vial (this is not provided by the lab).
Do not freeze in the syringe to avoid repeated freeze/thaw cycles since it could destroy the Q-REstrain molecules
Place the remaining 5 ml into the freezer immediately between -17°C and -23 °C (the colder the better). The Q-REstrain can be stored at this temperature for a maximum of 21 days.
If planning to infuse the second half longer than 21 days, it must be stored at -80°C (it is then stable for up to 6 months). Note: if splitting the doses into more than just half, split the doses and freeze them individually in cryo vials. Once again, do not freeze in the syringe
Premedication
To minimize any possible allergic reaction, RGCC recommends administering:
Mandatory: Dexamethasone 4 mg diluted in 0.9% Sodium Chloride 20 -50 ml bag right before administering the Q-REstrain or can be administered as a slow push (bolus)
Optional: A H2 Blocker (Famotidine, Cimetidine, Nizatidine) as well as Acetaminophen are recommended but are not mandatory. However, they are routinely administered to decrease any chance of headache, nausea, vomiting or diarrhea from occurring.
Famotidine 20 mg (or other as outlined above) diluted in 20 ml syringe. (Note: If giving orally, must be given six hours before the Q-REstrain is administered)
Acetaminophen 500mg of (Tylenol) P.O. and continue every 8 hours for three days if needed
Administration
Place an IV catheter using standard techniques and verify a good flow
Start with a minimum of a 50 – 100 ml bag of saline (using a 250 ml bag has been reported to result in the patient feeling better overall post infusion)
Infuse Famotidine as a slow push (wait 30-45 minutes before next step)
Infuse Dexamethasone as slow bolus push or rapid drip
Administer the Q-REstrain preparation (1/2 {5 ml} dose or {10ml} full dose) as a slow push at approx. 1 ml per 5 seconds (let the saline solution run a few seconds in between the 1ml slow push) through the IV route
After Q-REstrain has been infused, flush the IV access with 20 ml of normal saline solution
Monitor the patient for possible adverse reaction for the next 45-60 minutes
Remove IV catheter following standard procedures
Post Administration
Potential Side Effect
Headaches
Increased fatigue
Flu like symptoms
In Cancer - pain at surgical site can occur
In Cancer - TLS syndrome mainly with highly vasculated tumors (eg lung)
In Lyme or viral - co-infections can flare
What to avoid post administration
For Cancer (Apoptosis):
All therapies may be resumed (as outlined above) 14 days after administration
IV-C can be resumed after 7 days
For Virus/Lyme (V. Antagonist):
All therapies may be resumed (as outlined above) 7 days after administration
Wait at least 7 days after the Q-REstrain infusion to resume PEMF, Rife or HBOT
What not to avoid post administration
Biofilm busters
Oral detox supplements such as glutathione
Cytokine reducers
Binders
Routine supplements like multivitamins, vitamin D, probiotics, etc.
Foot baths
Risks with the Q-REstrain in cancer
Tumor Lysis Syndrome – TLS (fever, local edema, accumulation of fluid in the area of the tumor, etc) is a potential risk with Q-REstrain and patients should be properly evaluated prior to ordering the therapy. TLS occurs mainly with highly vasculated tumors (eg lung) or numerous tumors. It is important that physicians are educated on how to treat TLS if administering it to cancer patients at risk for this.
Even if the tumor load is under 5 cm and TLS is not a concern, the lysis of tumors can cause discomfort depending on the location of the tumors (bone, lymph nodes, rectal, etc.). Patients should be warned of this and a pain management plan should be in place
Follow Up/ General Info
Follow Up
For Cancer: Oncotrace or Oncotrail RGCC are recommended every 3-4 months after the administration of the Q-REstrain to evaluate the status of the CTC and the immunophenotypes.
For Viral or Lyme: The same lab that was used to order the Q- REstrain should be used to evaluate the status of the pathogen 4-6 months after the Q-REstrain administration.
Outcome
The RNAi technology has shown:
Cancer Patients: Approximately 78% of cases had a positive clinical outcome (Complete response or Partial response or Stable disease)
Virus Infected Patients: The positive clinical outcome reached 91%
Lyme Disease: Approximately 95% of cases had a positive clinical outcome (percentages include Borrelia, Bartonella and Babesia)
Parallel administration
For virus or Lyme – There is a minimum of seven (7) days between two different Q-REstrain. Upon our network experience a space at 21-30 days apart to give time to evaluate their patient before infusion the next one it is recommended.
For cancer – Three (3) to four (4) months apart with a maximum of four (4) in a 12-month period
Q-REstrain and Children
For Lyme/Viral: Q-REstrain for Lyme for children over the age of 5 (Reason: the sequence of interest has no overlapping parts with human genome)
For Cancer: Q-REstrain For malignancies for children over the age of 11 is at the discretion of the Physician. An evaluation of the thymus gland to verify it is atrophic is recommended for a child under the age of 10. (Reason: An overlapping of 60% of the Q- REstrain sequence may generate heterodimers between mRNA and Q-REstrain which has no consequence in adults, but in children when the clones of auto-epitopes have not been locked then there is a small (but not zero) possibility to create an autoimmune clone of B cells that may generate an autoimmune condition in the future. It’s important that the physician and the parents be made aware of this potential risk.
RGCC has not performed studies on children. The recommendations are based on published literature about the immune system and the thymus gland.
References
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