Peripheral Blood Stem Cells (PRP-PBSC)
TBI Therapy, LLC does not utilize nor advocate any FDA unapproved, speculative, or experimental stem cell technologies, including fat-derived stem cells, bone marrow stem cells (or bone marrow aspirate), or umbilical blood stem cells.
All stem cells utilized by TBI Therapy, LLC are isolated from peripheral blood, homologous, multipotent hematopoietic cells, or pluripotent very small embryonic-like stem cells. There is no manufacture nor manipulation of these peripheral blood stem cells or associated platelet growth factors (from platelet rich plasma) and all plasma or cells removed from the patient via a peripheral vein is administered to affected areas, homologously, on the same day.
TBI Therapy’s stem cell technology is performed in compliance with the exemption contained in Section 361 of the HCT/P Guidelines published by the FDA, as follows:
An HCT/P is regulated solely under Sec. 361 of the PHSA if it meets all of the following criteria:
- The HCT/P is minimally manipulated;
- The HCT/P is intended for homologous use only;
- The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage; and either:
- (i) the HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or (ii) the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and (a) is for autologous use; (b) is for allogeneic use in a first-degree or second-degree blood relative; or (c) is for reproductive use.
Hughes, J. (2018). Case Report for a mTBI Patient Treated with Intermittent Home HBOT, Intranasal and IV PRP Cocktail, Intranasal Pluripotent Stem Cells from Peripheral Blood, Intranasal Insulin, Cranial Osteopathy, and a Ketogenic Diet.
Hughes, J. (2016). Case Report for TBI (Traumatic Brain Injury) Patient Treated with A Protocol of HBOT (Hyperbaric Oxygen Therapy), Autologous Human Plasma, Cranial Therapy, EEG Biofeedback, IV Nutrition, and Adult Stem Cells.
For more research, see these articles and links below:
Regarding the VSELs (pleuripotent stem cells from the blood), see these links.
Regarding mesenchymal stem cells and their effects in the brain, see
Also, feel free to check out these webinars/lectures