Clinical Trials Home Page

The South Florida Bone Marrow/Stem Cell Transplant Institute is now running a new clinical trial protocol (08001-BMSCTI) for investigating a novel cancer therapy using transfusions of white blood cells from healthy donors. This investigative new cancer therapy was developed from the exciting research results of studying natural cancer resistance in a unique strain of lab mouse (SR/CR mice) and in some healthy humans.

This newly discovered innate activity for cancer resistance is mediated entirely by specific populations of leukocytes (specifically granulocytes and monocytes) that can be transfused from one individual to another for highly effective treatment of advanced cancers. We hope that the results from this clinical trial and other on-going research efforts will one day lead to an effective, nontoxic treatment that can provide clear clinical benefit to cancer patients who can no longer benefit from conventional treatments.

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.

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.

Clinical trial 08001-BMSCTI will study an investigational new cancer treatment. It will study the ability to transfer naturally occurring cancer-killing activity (CKA) in the granulocytes of selected donors into the body of a cancer patient.

Here's how the treatment 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.