Clinical Trials – Pending

We are currently working our way through 3 sets of clinical trials, these are;

Osteoarthritis
(Double blinded, Randomised, Placebo Controlled Trial)

Beginning of 2017, we have decided to formally push a clinical trial that will lead to yet another huge stepping stone in prooving the efficacy and safety of this treatment.

The largest issue we face is funding, it has taken many years to come to this point. This clinical trial will cost in excess of several million dollars. None of which will be rebated or funded through health insurance, medicare or government research schemes.

We aim to keep you up to date as this clinical trial progresses.

We are currently working with a fantastic team;

  • Dr. Ralph Bright – Principal and Coordinating Investigator
  • Prof.  Ian Harris – Orthopaedic surgeon and Coordinating Investigator
  • Dr. Amita Limaye – Cell biologist
  • Additional supporting members and statisticians to be revealed as this trial progresses.

The aim of this trial is to treat 2 arms of patients.

  1. Control group, provided with placebo injections.
  2. Stem Cell treatment group

Our aim is to clinically prove this treatment will be effective with good results and minimal adverse events. This  trial will proceed with complete Human Right Ethics Commitee (HREC) approval.

If you wish to learn more about how these stem cells work to treat osteoarthritis, please click on this link.

If you wish to learn more about proof of concept relating to this trial, please read the publications list or the 2017 literature review followed through this link.

 

Multiple Sclerosis

Some people inherit genes that make them susceptible for Multiple Sclerosis (MS). If these people get Epstein Barr Virus (EBV)(Herpes Virus 4) as a baby the infection will pass unnoticed. By the age of 10yrs everyone’s T-cells will have dropped to one third the number they had as a baby. The virus will not be eliminated. They will have glandular fever. Most will be very sick. Around 6 years later the first signs of MS will be noted. The virus first invades the B-cells on the surface of your tonsils. Then they will migrate down the crypts of your tonsil to the germinal centres where they infect the memory T-cells. This event gives them immortality. 20% of these memory B-cells will be auto reactive. Auto reactive cells are designed to attack any of your cells that are considered abnormal. This is part of the balance in your immune system that protects against cancer or other abnormal cells that may develop. The Epstein Barr Virus hides in your nucleus and uses the contents of your cells to function and to replicate. In this way it can escape detection and not be eliminated. It is the ultimate stealth attack! These infected B-cells circulate in the blood stream but will not attack the brain until the blood brain barrier (BBB) is damaged and they are able to cross over into the brain and start attacking the myelin sheaths. The BBB is a physical barrier formed by the cells that line all the blood vessels in the brain and spinal cord. The innermost cells are called endothelial cells. These are the BBB. While they are healthy the door is shut and the EBV infected B-cells cannot get in. Any damage to these cells opens the door and attacks begin, lesions form. Smoking damages endothelial cells. Other causes of damage include certain viral infections, high blood pressure and diabetes.

Endothelial dysfunction refers to the damage caused to endothelial cells all over the body. As endothelial dysfunction increases other problems surface such as atherosclerosis, heart attacks and strokes. Endothelial dysfunction can be measured with biomarkers such as nitric oxide (NO) and asymmetric dimethylarginine (ADMA). One hypothesis of this study is that we may be able to predict relapses before they damage the brain by measuring ADMA levels.

Treating endothelial dysfunction is part of treating MS.

Low contrast visual acuity testing is associated with cognitive performance in Multiple sclerosis2. This is a published pilot study in which Wieder and her group compared low contrast visual acuity (LCVA) testing to other accepted but more complex and time consuming measures such as Paced Auditory Serial Addition Test(PASAT) and RNFL as well as and the Symbol Digit Modalities Test (SDMT) and RNFL predicted CS. LCVA testing is simple, quick and appears to be accurate. No special training is needed to perform the testing.

Wieder demonstrated that LCVA was a measure of information processing speed and to a lesser degree, memory.

A second hypothesis of this study is that we can use LCVA assessment as a marker for MS progression or remission.

We aim to progress to a formal clinical trial by 2018

 

Renal Failure

We are currently applying for a Government Grant in order to carry out a Blinded Randomized Clinical Trial.

Further information about the treatment of Renal Failure and efficacy will be provided soon.

The progress of both of these trials will be updated on this website.