''It was a major challenge to shift from the education & training of allopathic medicine, with its emphasis on prescription drug use, to accept micronutrients as having a capacity to improve health." - Dr. Reginald McDaniel and others.
Dr. Reg's short biography is at the bottom of this page.


Health professionals in many disciplines can receive Continuing Medical Education credits for taking courses on glycobiology at
http://www.Proevity.com/

or at the Endowment for Medical Research, Dr. Reg's website.
http://www.EndowmentMed.org/



Background

In 1986, Phase 1 Food & Drug Administration {FDA} toxicity studies were conducted in dogs using a bioactive molecule extracted from the leaf gel of aloe vera. {1} A white powder comprised of chains of mannose sugars connected by B1-4 linkages had been isolated, stabilized, & named aloe polymannose {APM} or Manapol when formulated for human use and Acemannan for animal applications. {2}


No Toxicity - No Drug

An FDA new drug application was requested & Phase 1 toxicity studies were begun. Virtually no adverse effects were found in animal studies confirming to FDA new drug evaluation standards.
Efforts to make the extract from the aloe leaf gel a prescription drug under FDA guidelines were thwarted by prior drug regularatory law before passage of the DSHEA.

There were two major problems:

No significant toxicity could be elicited by the substance though given in massive amounts of animals & humans. This is in conflict with the accepted drug paradigm that drugs are poisons.


The second fact was that too many desirable responses were observed when the substance was added to the diet of humans suffering with virtually every category of disease.

This was drug paradigm heresy & challenged any reasonable persons' intelligence, particularly that of healthcare professionals.


Both problems were scientifically illuminated by a key review paper published in 1985.{13} It was shown in the cited review article that nine molecules of mannose are utilized in the endoplasmic reticulum to establish a domain organized on 3 chains extending from a peptide formed by the ribosome.


This domain is the site for further modification by glycosylation in the Golgi that codes for cell-to-cell communications by cytokines that control & initiate innate defense, repair, healing, & homeostatis at the cellular & intracellular levels.


A monosaccharide, mannose, that is difficult to differentiate structurally from glucose, was predicted to have vitually no toxicity.


Tissue culture & animal studies indicated that innate, gene-controlled production of antiviral {3}, anticancer {4}, vaccine adjuvant {5}, & healing {6} activities were promoted & supported by supplying this glyconutrient.


Furthermost, in vitro studies with human leukocytes indicated celluar synthesis of defensive & healing cytokines were increased over a concentration gradient. {7} This phenomenon was demonstrated when increasing increments of APM were added to cell cultures. Enzyme-Linked Immunosorbent Assay {ELISA} tests were performed to quantify interleukins, interferons, tumor necrosis factor, & colony growth factors. {7} 


Similar Cells Found

While conducting the toxicity studies in dogs, an observation was made in the acute intake studies that rare, large cells with abundant cytoplasm & vesicular, ovoid nuclei of known origin & cell type were noted on peripheral blood smears. The cellular diameter was over 10 times that of typical leukocytes.

A diligent search of peripheral blood smears taken from patients participating in an FDA pilot study in HIV-1 positive, symptomatic subjects that had received oral APM was made & similar cells were also identified.


Various isolation & concentration methods were used to try to collect a pool of the large cells. Observer embryologists, cytologists, histologists, & pathologists followed cells of the size & tintorial properties of our unknown cells to a wide range of final resting sites within animals & human organs & tissues. This was regarded to be why so many names were at one time or another chosen for the cells in question.{10}

It should be stated that our search suggests than in mammals the following sequence of published papers chronologically report on observations of the cell in question and indicate an active role in host defense:

1842 - Gulliver noted the cells in sections of phlebitis from horses.
1845 - Remak reported such cells in sections of calf spleens.
1874 - Eichhorst found 3 - 7 erythrocytes in the cytoplasm of the cells.
1892 - Metchnikoff observed & defined phagocytosis by the cells.
1907 - Rowley reported the large cells in normal human blood.
1919 - Shilling diagnosed bacterial endocarditis by finding bacteria in the cytoplasm of large cells on blood smears made from an ear stick.
1931 - Damashek, the leading hematologist of North America, declared that the large cells were not present in normal patient's blood, were extremely rare in ill patients, and of no clinical value.