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Due to a variety of plasma sources in terms of type of discharge, energy yield, working gas or geometric factors, it is recommended to standardize the study protocol by choosing a plasma source and easy access to rugged tumor surfaces as demonstrated by the CAP-plasma-jet. The intention of the trial shall be to optimize the plasma jet for tumor site capability and operating room implementation.
It makes sense to start clinical trials in plasma medicine with the treatment of head and neck squamous cell carcinoma patients of infected wounds and ulcerations.
CAP is able to reduce contamination of cancer ulcerations and the typical fetid odor that often accompanies head and neck cancer patients. The intention of the trial shall be to evaluate the efficiency of decontamination in head and neck cancer ulcerations in terms of pathogenic species, amount of reduction and reliability.
Standardize study protocol:
Phase I, clinical explorative single-arm, randomized, open, multicenter
Primary objective
Reduction of microbial burden of cancer ulcerations by application of CAP
Secondary objective:
Reduction of tumor following local CAP application
Inclusion:
20 Patients suffering from locally advanced oral cavity carcinoma with open tumor surfaces, treated with palliative intention and no more curative treatment options
Exclusion:
No wish for treatment, no compliance and understanding the protocol of the clinical study
Efficacy:
reduction of microbial burden; Documentation of visible changes by photography; Pathohistological and biochemical examination of specimen, taken from the tumor area and control areas
Procedure:
Plasma is applied for 1 minute per cm², spot area of 3 mm diameter distance between nozzle and tumor surface of 14 mm. 3 times/week with a break of 1 week followed by a repeated cycle for another week.
Conclusion:
The most important intention of the trial from the clinician’s point of view shall be to make CAP-treatment an effective and well-accepted addition to standard cancer therapy based upon EBM at least in palliative medicine.
The local anesthetic lidocaine, which has been used extensively during liposuction, has been
reported to have cytotoxic effects and therefore would be unsuitable for use in autologous lipotransfer.
We evaluated the effect of lidocaine on the distribution, number, and viability of adipose-derived stem
cells (ASCs), preadipocytes, mature adipocytes, and leukocytes in the fatty and fluid portion of the
lipoaspirate using antibody staining and flow cytometry analyses. Adipose tissue was harvested from
11 female patients who underwent liposuction. Abdominal subcutaneous fat tissue was infiltrated
with tumescent local anesthesia, containing lidocaine on the left and lacking lidocaine on the right
side of the abdomen, and harvested subsequently. Lidocaine had no influence on the relative
distribution, cell number, or viability of ASCs, preadipocytes, mature adipocytes, or leukocytes in the
stromal-vascular fraction. Assessing the fatty and fluid portions of the lipoaspirate, the fatty portions
contained significantly more ASCs (p < 0.05), stem cells expressing the preadipocyte marker Pref-1
(p < 0.01 w/lidocaine, p < 0.05 w/o lidocaine), and mature adipocytes (p < 0.05 w/lidocaine, p < 0.01
w/o lidocaine) than the fluid portions. Only the fatty portion should be used for transplantation. This
study found no evidence that would contraindicate the use of lidocaine in lipotransfer. Limitations of
the study include the small sample size and the inclusion of only female patients.