None listed
Conditions
Brief summary
This clinical pilot study examines feasibility and outcome of the tumour specific treatment for patients with advanced small cell lung cancer, Kidney cancer and Primary liver cancer . Procedures: UCMCs are isolated from the Umbilical cord blood and stimulated with different cytokines. The cells are reconstituted with fresh, complete culture medium until the mature immune cells are harvested on day 14. The small cell lung, liver and kedney cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week. The safety and effectiveness are investigated.
Interventions
UCMCs are isolated from the Umbilical cord blood and seeded in serum-free medium at a concentration of 10(7) cells / mL. The cells are stimulated with different cytokines, including IFN-Gamma, CD-3 monoclonal antibody and PD-1, The cells are reconstituted with fresh, complete culture medium until the mature immune cells are harvested on day 14. The small cell lung,liver and kidney cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subse
UCMCs are isolated from the Umbilical cord blood and seeded in serum-free medium at a concentration of 10(7) cells / mL. The cells are stimulated with different cytokines, including IFN-Gamma, CD-3 monoclonal antibody and PD-1, The cells are reconstituted with fresh, complete culture medium until the mature immune cells are harvested on day 14. The small cell lung,liver and kidney cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week at the same time. Treating clinician will be administering the intervention.The first single dose is initiated at 2X10(9) cells iv injection(Cell counting counter). If no side-effects, injection dosage increases to 10X10(9) on the second week, and escalates to 20x10(9) cells on the third week. The total injections are 3-6 times depending on the availability of tumour sample. The safety and effectiveness are investigated. For example, the phenotype (CD3, CD4, CD8, CD16, CD19, CD45RO and CD56), interferon-gamma,IL-2,IL-12,IL-17,IL-10,TGF-ß1 expression in the peripheral blood lymphocytes are measured before injection and one week after the third injection.
Sponsors
The First Teaching Hospital, Inner Mongolia Medical University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) Histopathological diagnosis of SCLC,Kidney cancer and Primary liver cancer; (2) KPS (Karnofsky performance score, KPS) score> 60 points or more; (3) is expected to complete chemotherapy or survival of at least 4 months, did not accept other anti-tumor therapy.
Exclusion criteria
(1) organ failure (heart function four, or liver function Child Pugh grading above grade C, brain metastases with disturbance of consciousness, or severe respiratory failure); (2) at the same time to accept other anti-tumor therapy (3) severe coagulation dysfunction; (4) patients with allergic to interleukin-2 or biologics; (5) a history of organ transplantation, the use of immunosuppressive agents or organ transplantation after long-term use of immunosuppressive agents; (6) patients with definite infection or unexplained fever (7) Pregnant and lactating women; (8) T lymphoma patients, infectious diseases, autoimmune diseases or other malignancies; (9) HIV-positive, drug addiction.
Outcome results
None listed