Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation
Denmark30 participantsStarted 2020-10-01
Plain-language summary
To investigate safety of treatment with allogeneic adipose tissue-derived mesenchymal stromal cells (ASCs) in patients undergoing lung transplantation, to evaluate whether the treatment can reduce host immunological reaction towards the graft, and to reduce the ischemic reperfusion-injury after transplantation.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
* Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 3 months.
Exclusion Criteria:
* Recipients of multi-organ transplant, and or previously transplanted with any solid organ, including previous lung transplantation.
* Patients scheduled for single lung transplantation.
* Patients in need of acute transplantation e.g. patients on urgent call for transplantation and patients on respirator or on extra corporal membrane oxygenation (ECMO) treatment at time of transplantation.
* Patients that based on crossmatch prior to transplantation have need for additional immunosuppressive treatment
* Donor lung cold ischemic time \> 12 hours.
* Patients with platelet count \< 50,000/mm3 at the evaluation before transplantation.
* Patients who are unlikely to comply with the study requirements.
* Patient unable to participate in the study for the full study period
* Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
* Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation…