We urge healthy young people and qualified cancer patients to participate in this trial as granulocyte donors and as study subjects in a collective effort for fighting against cancer as one of the worst enemies to mankind.
There are over 100 million cancer patients in the world – 10 million of them in the US alone. Each day, over 16,000 of these people die because there is no effective treatment for them, or because they no longer respond to conventional cancer therapies. For such people, a new kind of therapy is their only hope for survival.
LIFT is an investigational new cancer treatment that will transfer naturally-occurring cancer-killing activity (CKA) in the granulocytes of a selected donor into the body of a cancer patient.
Here's how the LIFT method works:
- Donor selection: Healthy young volunteers will be screened for the level of CKA, blood types, HLA types, infectious disease status, CMV status etc. by blood tests and physical examinations. The selected volunteers will become part of the Donor Registry. The test results of selected volunteers will be used to match with specific patients.
- Granulocyte collection: When a qualified patient is identified for treatment, granulocytes from several matched donors in the donor registry will be mobilized by two medications and collected by a well-established medical procedure called "apheresis" or "pheresis." A pheresis machine separates donor granulocytes from other blood products that will be immediately returned to donors so that the health impact on granulocyte donation is much smaller than on whole blood donation. Granulocyte mobilization and collection by apheresis have been used in clinical practices for a long time with very good safety record.
- Patient selection and granulocyte infusion: Qualified patients will be selected according to general health condition, disease status and match criteria. Freshly collected granulocytes from matched donors will be given to patients via IV infusion. Granulocytes cannot be stored or shipped for later uses.
LIFT Research Study
Granulocyte infusion therapy has been traditionally used for treating neutropenia-related infections for over 30 years with excellent safety records. Since a significantly higher dose of granulocytes for each patient is proposed in our new cancer treatment, the primary goal of this clinical trial is to test whether the recipients can tolerate the proposed dose of granulocytes.
The main focus of the trial is the possibility of developing Transfusion-Associated Graft vs Host Diseases (TA-GVHD) and other potential side effects in the study subjects at higher doses of donor granulocyte.
Donor granulocytes per se are not known to produce TA-GVHD. However, granulocytes collected via apheresis may contain with some donor T-lymphocytes that in some rare occasions can produce various degrees of TA-GVHD in some individuals, especially the recipients with immune suppression. If possible, we will also make observations on the efficacy of this treatment on the study subjects with measurable diseases of cancer. We will recruit 22 cancer patients as study subjects for this trial.
This research study has met all regulatory requirements including approval by the Wake Forest University School of Medicine’s Institutional Review Board (IRB) and been granted IND (Investigational New Drug) status by the Food and Drug Administration (FDA). It is currently registered at clinicaltrials.gov and the PDQ database of National Cancer Institute.
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