INITIAL PROOF OF CONCEPT CLINICAL TRIAL
HUMAN CLINICAL TRIAL PRIMITIVE CELL INCREASE
A versatile protocol was developed that would be acceptable in the United States, Europe and Asia. An outside Clinical Data Management company was hired to do the randomization and control the data including the data collection process. Protocols for a Human Clinical trial were written, and IRB approval was obtained. The trial was a randomized, double blind, placebo controlled Human Clinical Trial managed by an outside Clinical Data Management company. All participants were thoroughly screened and given physicals including blood tests to assure they were healthy and all blood work was within acceptable limits.
The blood tests were completed on each person prior to the test, at two weeks, four weeks, and two weeks after the trial was completed and measured circulating primitive cells and the following:
WBC, RBC, Hb, HCT, MCV, MCH, MCHC, PLT, LYMPH%, MONO%, NEUT%, EO%, BASO%LYMPH%, LYMPH#, MONO#, NEUT#, EO#, BASO#, RDW-CV, RDW-SD, PDW, MPV, PCT, TP, ALB, A/G, TBIL, DBIL, ALT, ALP, CRE, UREA, GLU, IgM, IgA, IgG, CD8, CD4, CD3, CD4/CD8
The participants were given an escalating dose beginning at one fourth the recommended serving for one week, then one half the recommended serving for one week, then three fourths of the recommended serving for one week, and finally the full serving for one week.
Cell counts were performed along with the blood test listed above. Day 0 a baseline was determined for each participant. After two weeks the average increase in circulating primitive cells was 117.9%, after four weeks it was 268.8%.
CELL LINE ASSAY
LIFESPAN STUDY ON C. ELEGANS
WOUND HEALING IN MICE STUDY
HORSE STUDY ON 5X RECOMMENDED DOSE
The product is not administered on a strict mg/Kg basis; it is recommended that 10 grams a day be given to adult horses. The horses in the trial weighed between 900 and 1,100 lbs. The normal dosage for the horses in the trial was from 20 to 24 mg/Kg and at 5 times the daily dosage the horses received between 100 and 120 mg/Kg. The veterinarian’s observations at the completion of the trial was that all horses appeared to have a shinier coat, the horses responded better to riders and grooms. Hoof growth was quality significantly accelerated, hoof quality was significantly improved, and several had put gained weight, apparently in the form of more muscle.
CANINE STUDY INCREASE IN CIRCULATING PRIMITIVE CELLS
The trial was performed on 20 healthy dogs that were under the constant supervision of a veterinarian in Aiken, South Carolina. The dogs were given blood test measuring over 20 aspects of the blood prior to being placed on the PrimiCell® product and seven weeks later. All blood work showed no adverse effects.
The results of a study with dogs in South Carolina closely resembled the similar study with humans. The average percent increase in circulating primitive cells after two weeks was 96.2% and at the end of four weeks the average percent increase was 281.3% The Veterinarian in charge has observed improvement in the composite score represented by 5 major areas: Appearance, Performance, Behavior, Attitude, and Responsiveness.