Lung transplantation MedDRA version: 21.1 Level: LLT Classification code 10066204 Term: Chronic lung disease of prematurity System Organ Class: 100000004855
Conditions
Interventions
Product Name: CSCC_ASC
Product Code: CSCC_ASC2210
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: CSCC_ASC2210
CAS Number: CSCC_ASC2210
Current Sponsor code: CSCC_ASC2210
Oth
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 12 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 with a planned ECMO treatment when lung is transplanted. • Patients that during lung transplantation unexpected have a need for ECMO support • Patients that needs crossmatch prior to transplantation • Donor lung cold ischemic time without oxygenation > 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Difference in incidence and grade of PGD at 72 hours after transplantation;Timepoint(s) of evaluation of this end point: 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints Difference between groups of: 1. Glomerular Filtration Rate 2. Rejection episodes and graft loss 3. Measurements of inflammatory variables 4. Measurements of de novo HLA-specific antibodies 5. Tracking of infused ASCs in lung biopsies 6. Quality of life Safety endpoints Difference between groups of: 1. Patient adverse events and serious adverse events 2. Laboratory evaluations including serology to test for acute antibody mediated rejection ;Timepoint(s) of evaluation of this end point: Week 12 after treatment | — |
Countries
Denmark
Contacts
Public ContactJens Kastrup
Rigshospitalet
Outcome results
None listed