Status:
UNKNOWN
Safety Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection
Lead Sponsor:
Alliancells-PuRui Biocience Co., Ltd.
Collaborating Sponsors:
Zhongyuan Union Stem Cell Bio-engineering Corporation
Conditions:
Hepatocellular Carcinoma
Renal Cell Carcinoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a major histocompatibility complex-unrestrict...
Detailed Description
It was estimated that 2.6 million people suffer from cancer and 1.8 million die of cancer in China yearly according to the Annual Report of Cancer Registration in China 2012. So far, the main treatmen...
Eligibility Criteria
Inclusion
- Male or female patients over 18 years of age.
- Patients who give written informed consent.
- Patients with solid tumor already had radical resection
- Definition of radical resection in this study:
- All tumors were moved out, with a clean resection margin.
- No distance metastasis.
- No major post-operative complication.
- Without any anti-cancer medication within the past 15 days.
- The following laboratory parameters: Platelet count \>= 70 x 109/L; Hemoglobin \>= 8.5 g/dL; Albumin \>= 3.5 g/dL; Total bilirubin \<= 25umol/L; Alanine transaminase (ALT) and AST \<= 2.5 x upper limit of normal; Serum creatinine \<= 1.5 x the upper limit of normal; Prothrombin time (PT) \<= 3 seconds above control.
Exclusion
- History of cardiac disease.
- Active clinically serious infections
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- History of organ allograft.
- Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- Pregnant or breast-feeding patients.
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01914263
Start Date
March 1 2014
End Date
June 1 2016
Last Update
April 16 2015
Active Locations (3)
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1
Hannan BOAO Life infinity international anti-aging medical center
Qionghai, Hainan, China, 571434
2
The 210 Hospital of Chinese People's Liberation Army
Dalian, Liaoning, China, 116021
3
The 323 Hospital of Chinese People's Liberation Army
Xi'an, Shaanxi, China, 710054