Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).

Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University; YUKIGUNI COMPANY

Criteria

Inclusion Criteria:

• MSKCC patients age 18 or older able to sign informed consent

• Absolute Neutrophil count >0.5 K/mcL

• Diagnosis of MDS by bone marrow biopsy

• Patient not a candidate for aggressive standard treatment

Exclusion Criteria:

• IPSS (High risk)

• History of AML

• History of Stem Cell transplant

• Known history of HIV+

• Allergy to mushrooms

• Bone Marrow blasts >10%

HEALTHY CONTROL ELIGIBILTY CRITERIA

Inclusion Criteria

• Age ≥55 years

Exclusion Criteria

• Currently taking corticosteroids or other immunosuppressants

• Known history of HIV+

• Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years