What are IPSC cells?

The IPSC cells (AKA induced pluripotent stem cells) are hematopoietic stem cells. Their role is to give rise to other blood cell types. They are normally found in the bone marrow of (pelvis, femur, sternum), umbilical cord blood and peripheral blood. They are quiescent in nature which gives them the ability to survive in the hypoxic environment of the tissues they reside in. However, when they are “woken up,” they will have a high self-renewal capacity, multipotency and increased mobility.

How are IPSC Cells made?

RGCC uses magnetic beads and FACS (fluorescence-activated cell sorting) isolation methods to identify and isolate CD34 cells from peripheral blood. Cells are then cultivated with media and supplements that induce greatly the proliferation of your hematopoietic stem cells. Once their numbers are adequate, they are sent directly to the patients’ practitioner for infusion. They can be kept in LN (Liquid Nitrogen) tanks until requested. The thawing from LN needs to take place very fast (in just a few minutes) so that the iPSC loss will only be around 2.5 to 3%. This procedure is very well known for those already using autologous transplantation after.

The platform used is based on the fact that from these cells you may get several lines of differentiation by reprogramming. Therefore, they are able to be effective for more than just one tissue type (vascular, joint, etc.).

Quality control is performed on every step of the process until the final product is ready and safe for use. QC involves monitoring the cell culture for microbial contamination, and the cells themselves for specific marker expression.

Are these embryonic stem cells?

These are not originated from embryos but from each individual’s blood and therefore are NOT embryonic iPSCs.

Are the IPSC genetically altered?

The cells have had no genetic (DNA) tampering whatsoever and will have a document of sterility accompany each sample. You will be given the estimated number of iPSC’s received for each person. This is helpful to guide the practitioner as to how many cells are given especially in joint injection therapy.

What is the goal of IPSC?

• The goal is to replace damaged tissue.

Are IPSC useful for cancer?

• IPSC’s have no direct anticancer effects. However, in many studies they have been used in combination with chemo (Mega Therapy) or as an adjuvant arm in immunotherapy.
• IPSC’s can be harvested prior to chemotherapy and used post treatment to help replenish and repair. Their primary use is to replace damaged tissue.

Note: Only genetically engineered (DNA manipulated) IPSC’s have anticancer effect but they are not allowed to be used in the clinical field at this time.

What kind of conditions can be treated with IPSC?

• Non-cancer: Thalassemia, sickle cell anemia, aplastic anemia, Fanconi anemia, immune deficiency syndromes and autoimmune diseases, Alzheimer’s, Parkinson’s, glaucoma.
• Repair of damaged tissue from previous diseases, medical conditions, degeneration, surgery, cancer treatments, etc.

Are there any contraindications to IPSC?

• Under 18 years old
• Arrhythmia
• Hypertension
• Dyspnea
• Active autoimmune diseases
• Active infections including Lyme or Lyme related coinfections
• Recent cytotoxic chemotherapy and/or radiotherapy
• Cachexia
• Scar tissue in the area of administration.

Are IPSC safe?

• IPSC’s are generally considered very safe.

Is there research on IPSC for IV protocols?

• A: Yes. See below:

www.ncbi.nlm.nih.gov/pmc/articles/PMC5118044/
www.ncbi.nlm.nih.gov/pmc/articles/PMC6332789/

What is the administration schedule of IPSC?

• 2 doses:
  • 1 dose - Day 0
  • 2nd dose - Day 14.

What is included in the IPSC package and what is the cost?

• Costs vary per RGCC practitioner. Please inquire of the clinic for their charge. Package price does include two doses of the IPSC.

What pre-requisite tests are required to establish baseline for IPSC?

• Recommended to have confirmation that patient does not have an active infection (CRP >3)
  • Active infections –(includes active Lyme and coinfections) - Indicators:
    • WBC >10,000
    • Lymph > 20%
    • CRP >3.0
• Recommended to have confirmation that your patient is not highly inflamed:
  • High inflammation - Indicators:
    • CRP>3.0)
    • Sed Rate >29 mm
    • AGP- a1-acid glycoprotein >110
    • ANC <2500 (indicator of immune insufficiency)
    • Hemoglobin <8.5
• Recommended to have confirmation that patient does not have active auto immune condition

What is the recommended follow up for IPSC?

Clinical monitoring - depending on the regenerating tissue or organ:

• Anatomical diagnostic, CT, MRIs, US etc.
• Functional testing, LFT, enzyme activity, eGFR etc.
• Direct cellular or molecular monitoring. Detect the level and the activity of progenitor cells of the damaged tissue.

How much blood is required for IPSC?

• Dose 1 and 2 of IPSC (Draw 75-90 ml) 3 vials.

What pre-medications are required for IPSC?

PRE-MEDS: Administer pre-medications prior to each dose of the THERAPY.

For IV:

• Mandatory: 4 mg dexamethasone I.V. in a 20-50 ml rapid drip saline solution or slow bolus push.
• Recommended: H1 Inhibitor – IV or oral.

For Joints: 1 – 2% Lidocaine prior to injection.

What needs to be avoided prior to the IPSC?

• Avoid other therapies for 14 days prior to IPSC blood draw and actual administration.
• Recent cytotoxic chemotherapy and/or radiotherapy – allow a window of 2-3 weeks
• Medications like cytokines/hormone therapy (specifically Estrogen and HGH)

What needs to be avoided after IPSC?

• Avoid other therapies for 14 days after the administration of the IPSC
• Recent cytotoxic chemotherapy and/or radiotherapy – allow a window of 2-3 weeks
• Medications like cytokines/hormone therapy (specifically Estrogen and HGH)

Are there any possible adverse reactions with IPSC?

The adverse reactions are not considered life threatening (NCI grade 1) – expect high blood pressure (last couple of days), a kind of arrhythmia (not ventricular fibrillation), a small degree of bronchospasm; may develop symptoms of photophobia, vomiting (if pressure builds up in the CNS) – can monitor blood pressure.

• Cardiovascular (hypertension, arrhythmia etc.) (47.6%)
• Pulmonary (dyspnea, hypoxia) (13.6%)
• Constitutional (3.4%)
• Neurologic (1%)