Status:
UNKNOWN
Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Lung Transplant Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 hos...
Detailed Description
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow (BMSCs) or adipose tissue (ASCs) have proven their po...
Eligibility Criteria
Inclusion
- 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
- 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, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04714801
Start Date
October 1 2020
End Date
November 30 2024
Last Update
July 16 2021
Active Locations (1)
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1
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, Denmark, 2100