Primicell Study
“Stem cell research can revolutionize medicine, more than anything since antibiotics.” ~Ronald P. Reagan
THE SCIENCE—BACKGROUND & STUDIES—BEHIND PRIMICELL® AND ITS DERIVATIVES
GENESIS
Over seven years ago, the decision was made to develop a nutraceutical that could increase circulating primitive cells. It was hope that this nutraceutical could improve overall wellness and facilitate hematopoietic stem cell treatments. In particular, in the United States where incubation of hematopoietic stem cells is not allowed for human autologous treatments. Because the product was developed to increase circulating primitive cells, it was named PrimiCell®. PrimiCell® is not a drug. It is a combination of phytonutrients that have been processed using a proprietary system and equipment.
As testing and experiments progressed, a significant body of anecdotal information came to light. The decision was then made to take testing of the product to the next level. In order to do so, a team of world-class Medical Doctors specializing in pharmaceutical testing and toxicology were brought together.
OUR CLINICAL TEAM
Our advisory team consists of 3 highly accomplished physicians with impressive CVs and major clinical research experience with global companies. They are: A retired Harvard Medical School professor, who over 20 years ago, sold his ear nose and throat practice and began a new career developing effective human clinical trials. The next member is a Medical Doctor from China with a PhD in toxicology. He is an associate professor University of Albany. The third member is a Medical Doctor from Saint Petersburg, Russia. She has worked for over 20 years in the pharmaceutical industry and human clinical trials.
INITIAL RESEARCH — PROOF OF CONCEPT
The obvious question in any new product is: Does it work? Our first step was a very simple proof of concept test. 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. While this is not a conclusive test, however when considered with the known anecdotal information, it was enough to justify a Human Clinical Trial. (Fig 1)
Figure 1
CONFIRMATION—MULTIPLE STUDIES FOR MULTIPLE HUMAN CONDITIONS ALL GENERATING SUPERIOR OUTCOMES
- Human Clinical Trial. The Advisory Team developed a versatile protocol 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 an IRB was approved. The trial was a randomized, double blind; placebo controlled Human Clinical Trial managed by an outside Clinical Data Management
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. At each blood draw, circulating primitive cells and the following were reported: 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%. (Fig 2)
Figure 2
- Cancer 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. 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) cancer cells. (Figs 3 and 4).
Figure 3
Figure 4
- Anti-Aging. The next tests were done 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. (fig 5)
Figure 5
- Heavy Metal Toxicity Further testing with C. elegans in the heavy metal toxicity resistance experiment, the resistance of C. elegans to Cr6+ toxicity cultured in PrimiCell® extracts was significantly increased in comparison to the controls.
- Anti-Oxidant. In anti-oxidation experiments, the survival rate of the elegans cultured in PrimiCell® to H2O2 treatment was significantly increased.
- Heat Stress In the 34°C heat stress experiments, the survival rate of C. elegans was increased with PrimiCell®.
- Wound healing in Mice. A study was done to determine if any wound healing benefits were derived from the 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 as shown in fig 6.
Figure 6
- Skin Repair – Pain Relief. Similar tests were done on mice for skin repair and nerve damage pain The Skin Repair test showed PrimiCell® treatment could facilitate the skin wound healing process and the Nerve Damage test demonstrated an analgesic effect of PrimiCell® as evidenced by its capability of curtailing the decrease of pain threshold caused by sciatic nerve ligation-induced injury. These results suggest that PrimiCell® formula could be developed as pain reliever to promote nerve injury repair in the conditions such as sciatic nerve injury.
Bottom Line: PrimiCell® works and like Stephen Hawking has repeatedly said…
“…Stem cell research is the key to developing cures for degenerative conditions”
ANIMAL TESTING—HORSES, HOGS & FARM ANIMALS
Horses: All ingredients in the PrimiCell® have been fed to horses for many years with no negative side effects whatsoever. Based upon those results, the product was given in low doses to thoroughbreds overseas. The doses were gradually raised until an effective dose was determined. Hundreds of horses have now taken the product, with a slight formula modification to increase the efficacy for horses (Equine Regen® Plus), 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 re-confirm product safety, under the direct supervision of a veterinarian in Aiken, South Carolina, horses were fed five 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 effect. 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 weighted between 900 and 1,100 lbs. The normal dosage for the horses in the trial was from 20 to 24 mg/kg and at five 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 trainers, hoof growth was significantly accelerated, hoof quality was significantly improved, and several had put on additional weight in what appeared to be more muscle.
The increase in circulating primitive cells was a surprise…ranging from 957% to 1,524%. (Fig 7)
Figure 7
Laminitis. There have been no scientific tests for efficacy related to laminitis. However, there have been many incidences in both Overseas and the United states where severe cases of laminitis that have not responded to long term treatment have gone away after one to three months on the product. Additional studies need to be done to confirm this is not coincidence.
Hogs. Based on a client’s request, we conducted a four-week study on young show hogs. All hogs were healthy and in the 50 lb range when the trial started. The trial was a double blind, placebo controlled test to determine what if any effect the PrimiCell® would have on the hogs. The blood test from the hogs showed no blood issues as a result of the trial and circulating primitive cells significantly increased. Hogs in the PrimiCell®groupputonmoreweightthantheothergroups.
Bottom Line: Based on multiple tests in multiple countries, PrimiCell® works on Humans, Horses, Hogs, Dogs, Mice & Farm Animals
MAN’S BEST FRIEND—ALONG WITH VETERINARIANS, DOG TRAINERS, CLINICIANS & PET PARENTS—KNOW THAT OUR PRIMICELL® INFUSED CANINE REGEN® PRODUCT TREATS HELPS BUILD HEALTHIER, HAPPIER & MORE ACTIVE DOGS!
Shortly after we developed our equine product—Equine Regen® Plus —we began receiving communication from people, who had given the human version, PrimiCell®, to their dogs and they were praising the benefits. We felt we needed to immediately do testing to confirm our belief. The trial was performed on 20 dogs that were under 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. Seven weeks later, all blood work showed no adverse effects. (Fig 8).
Due to time pressure and logistical issues, circulating primitive cells were not counted. The Veterinarian in charge made some observations that were all positive related to coat appearance, stamina, recovery, and responsiveness.
Figure 8
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 5 major areas, Appearance, Performance, Behavior, Attitude, and Responsiveness.
Figure 9
In Summary—Years of Clinical Research on Humans, Horses, Farm Animals & Dogs— prove beyond a doubt that PrimiCell® is a safe, breakthrough product that works!