The Effects of AMPC in the Treatments of Refractory or Relapsed AML

Overview

A private trial for evaluating the overall response rate contributed by AMPC in AML in refractory or relapsed AML

After inclusion and exclusion criteria has been determined and approved, written informed consent will be obtained from the candidate. All medical history relevant to the diagnosis of AML will be collected. Screening period: The screening period could extend from 0 to 7 days depending on the completion of screening laboratory results as below. On day -5 (up to day -1), the patient will undergo a screening test for the following test items: * BUN, creatinine, electrolyte, liver function test (LFT) * Full blood count (FBC), including blood smear * Hepatitis B/C * Human T lymphocytic virus type I and II (HTLV-I/II) * HIV1/2 * Syphilis serology * Mycoplasma serology For Hepatitis B/C,HTLV-I/II, HIV1/2, Syphilis serology, and Mycoplasma serology, these tests obtained up to 3 months prior to day -5 can be allowed for using as screening result. * Chest X-ray * Bone marrow study including aspiration with wright's stain, biopsy, flow cytometry, and chromosome study (Any molecular testing for AML is optional.). Bone marrow biopsy can be omitted if the prior study performed within 14 days before day-5 and the available materials (core biopsy and slides) and result can be obtained for pathological review. In this case, only bone marrow aspiration for Wright's stain, flow cytometry, and chromosome study will be performed. Bone marrow biopsy will be repeated if the previous result has been performed more than 14 days prior to day -5 and/or FBC at day -5 reveals peripheral blast count higher than 10% of total white blood cells. For chromosome study (cytogenetics), the previous result before the recent line of chemotherapy prior to enrollment can be used for the screening data. On day 0, peripheral blood will then be collected, ranging from 250mL to 400mL depending on candidate fitness. The blood is collected into a sterile blood bag and sealed. Subsequent processes will be conducted in the blood bag within a closed-system to minimize contamination risks. FBC will be collected in order to determine the disease status. After that, the investigator will consider to prescribe blood transfusion for the candidate. On day 0 to day 3, the collected blood will be sent to the laboratory for stem cell culture, and a sample of the collected blood will be sent to a third-party laboratory for contamination testing of the following parameters: * Bacterial endotoxin * Total viable aerobic count * Total viable count * Microbial growth * Mycoplasma real-time PCR test On day 4, the biotest results will be released and the safety profiles of the AMPC product must be completed and passed before the cultured stem cells may be released for treatment On day 5, candidates will receive an infusion of the cultured stem cells. Prior to the infusion, FBC and blood chemistry (BUN, Cr, electrolyte, LFT) will be collected and the treating doctor will first conduct an allergy skin test to determine suitability for reinfusion. The cultured stem cells are then reinfused intravenously into the candidate in a process that could take up to 2 hours The candidate participation will take place on day 0 to day 1 or 2 (if blood transfusion is required) and day 5 (period adjusted for blood transfusion if required) for peripheral blood collection and stem cell reinfusion respectively; with 12 month follow up after treatment; * 3 days post-treatment follow-up: full blood count test and blood smear, BUN, Cr, electrolyte, LFT * 10 days post-treatment follow-up: full blood count test and blood smear, BUN, Cr, electrolyte, LFT * 1 month (+/-7 days) post-treatment follow-up: full blood count test and blood smear, BUN, Cr, electrolyte, LFT, bone marrow study * 3 month (+/-7 days) post-treatment follow-up: full blood count test and blood smear, BUN, Cr, electrolyte, LFT, bone marrow study * 6 month (+/-7 days) post-treatment follow-up: full blood count test with bone marrow study * 12 month (+/-7 days) post-treatment follow-up: full blood count test with bone marrow study

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Eligibility

Locations (1)

Outcomes

Central Contacts