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May 10, 2011

Leukocyte Infusion Therapy Clinical Trial in China


The Leukocyte Infusion Therapy (LIFT) for cancer treatment pioneered by Dr. Zheng Cui of Wake Forest University has a clinical trial proceeding in China. The process is a simple transfusion of certain immune system white blood cells from people who are naturally immune to cancer to boost the immune system of people with weaker immune systems.

While many of Dr. Cui’s preclinical and preliminary clinical studies have shown promising results and the FDA has approved a combined phase I-II clinical trial in the US which is currently in process, a lack of conventional funding has limited the access of many patients to the US trial. Due to the significantly lower cost of medical procedures in China, it is now possible to conduct the clinical trials for testing LIFT in China for a larger number of subjects.

The first clinical trial in China is taking place at the 304 Hospital in Beijing and its lead investigator is Dr. Wenhua Xiao. It will include twenty-six patients and you can read more about it in the Who Can Participate? section.



It is highly unlikely that LIFT trial will be funded by conventional sources. A possible funding mechanism for conducting clinical trials to test LIFT is to gain grassroots support from charitable donations, direct support from trial participants and possibly the support of commercial entities that focus on developing technology-based treatments. If the trials successfully prove that LIFT can help increase patient lifespans, the treatments will be available at any hospital for only the cost of the medical procedure.

The trial estimated cost for each patient is more than $137,000.

The cost for treating patients in the China trials is estimated to be significantly lower than that in the US trial. The lower cost should allow the speed of data acquisition to accelerate rapidly. If successful, it will help greatly to make the treatment available in all hospitals in China rapidly which will help mankind.

By conducting the trial in China, we are enabling international subjects to participate in the trial at a significantly reduced cost vs a trial in the US, even considering the additional travel costs to China. Of course, patients that participate in this trial must be willing to spend a minimum of one month in China, deal with partial language barriers, and adapt to a different type of hospital experience.

Breakdown of costs associated with the trial for each subject in China:

- Recruitment of donors
- Evaluation of donors (Over 25 donors tested for each patient)
- Donation Processing
- Doctor and Nurse Fees
- Testing including blood, MRIs, etc.
- Trial administration Costs
- Coordinator Costs

Procedure

Granulocyte transfusions have been used in clinical practice for more than 30 years to treat patients who have life-threatening infections and have very low white cell count following chemotherapy. In that setting, granulocyte infusions are given to help the patients fight infections. In this clinical trial granulocyte infusions are given to hopefully help you fight cancer.

We estimate that 5 infusions will be needed to achieve our target cell dose. Transfusions of white cells will be administered daily. It is possible that treatment interruptions might occur, and treatment delay up to 7 days is allowed.

Donors will be asked to take dexamethasone (a steroid pill) and/or filgastrim (Neupogen)) the night before collection of cells. These two medications are widely used in clinical practice to increase the yield of white cells during collection.

White cell infusions might be administered before infectious disease marker results obtained on the day of collections from the given donor are available from the Red Cross. All donors registered to this study will be tested and screened for infectious disease markers at the time of donor registration and they will be re-tested in American Red Cross on the day of donation. Granulocytes are generally available for transfusion within approximately 24 hours after collection; at that time the infectious disease markers obtained on the day of collection are generally not yet available. Donors will have had recent (within 30 day) infectious disease markers to exclude known blood-borne diseases, and will have passed the universal donor questionnaire on the day of donation. This practice is consistent with current clinical practice, given the short life span of granulocytes. Results of these tests will become available and will be shared with you.

Your doctor may give you medications to prevent transfusion reaction, and/or to treat the reaction should it occur. Such medications may include acetaminophen (Tylenol), diphenhydramine (Benadryl) and/or hydrocortisone (a steroid).

You will be monitored closely daily with blood tests during treatment, and monthly after treatment. Your cancer will be assessed three months after the treatment is finished. You might receive other treatments for your cancer if it is getting worse during that time. If your cancer is not getting worse, you will be asked not to take other treatments for your cancer during those three months.
How long will I be in the study?

We think you will be in the study for approximately 3-5 months. The researcher or your regular doctor may decide to take you off this study if:

• The treatment does not work in your cancer.

• Your health gets worse.

• Your cancer begins to grow.

You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the researcher and your regular doctor first.

Who can Participate?

The first clinical trial in China will take place at 304 hospital in Beijing and will focus on frequency of dose testing in twenty-six subjects of patients who have exhausted traditional therapies and are determined to have stage II to Stage IV cancer. Patients enrolling should have one of the following types of cancer:

Liver
Pancreatic
Colorectal
Lung
Melanoma
Breast
Sarcoma
Ovarian


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