PRIMICELL®
CLINICAL &
RESEARCH STUDIES

INITIAL PROOF OF CONCEPT CLINICAL TRIAL

Three healthy adults with no illness and normal blood tests were selected. Their blood was drawn and the primitive cells counted to determine a baseline. All three were then given PrimiCell® and two hours later their blood was drawn and the cells counted again. The results showed a significant increase in circulating primitive cells.

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

Following the human clinical trial, additional testing was done on PrimiCell®. Among the first were two assays, CCK-8 and SRB to determine the effect PrimiCell® had on selected cancer cell lines. The results of CCK-8 and SRB experiments suggest that PrimiCell® extracts may have anticancer effects on certain lines of cells. At the cellular level PrimiCell® showed significant inhibitory effects on the cell growth of A549 (non-small cell lung cancer), SGC-7901 (Stomach cancer), HT-29 (colon cancer), and PC-3 (prostate cancer).

LIFESPAN STUDY ON C. ELEGANS

The test was used to determine if PrimiCell® had anti-aging properties. Pods of 90 C. elegans were used as control and others were given PrimiCell®. The results showed the lifespan of C. elegans was significantly prolonged with PrimiCell®. Similar results were obtained from experiments with both liquid media and solid agar plates.

WOUND HEALING IN MICE STUDY

A study was done to determine if any wound healing benefits were derived from the product. Three points were measured, lesion size, inflammation, and necrosis. All groups were acclimated for one week followed by one week either being fed PrimiCell® or a saline solution. The PrimiCell® group showed significant improvement over the control group in all three areas.

HORSE STUDY ON 5X RECOMMENDED DOSE

All ingredients in PrimiCell® have been fed to horses for many years with no negative side effects. Based upon those results, the product was given in low doses to race horses in the United states and overseas. The doses were gradually raised until an effective dose was determined. Numerous of horses have now taken the product, with a slight formula modification to increase the efficacy for horses, and no bad side effects have been noted. The horses have been mostly performance horses, thoroughbreds, polo ponies, cutting horses, and barrel racers. Anecdotal comments by horse owners have noted many benefits including, quicker recovery after exercise, horse puts forth more effort yet is still more manageable, hoof strength improved. To confirm product safety at high doses, under the direct supervision of a veterinarian in Aiken, South Carolina, horses were fed 5 times the recommended daily serving for three months. Complete blood work was done before the trial started and at one month, two months, and three months. Only healthy horses were used in the trial and at the end of the trial all horses blood work showed no adverse effects.

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.