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Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation

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ClinicalTrials.gov Identifier: NCT04714801
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE May 29, 2020
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
Pulmonary graft dysfunction (PDG) [ Time Frame: 3 days after treatment ]
Reduction in incidence and grade of Primary graft dysfunction (PGD) after transplantation in ASC treated patients compared to controls. Primary graft dysfunction is defined, according to the International Society for Heart and Lung Transplantation (ISHLT), as pulmonary infiltrates and hypoxemia occurring in the first 72 hours after transplantation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Glomerular Filtration Rate [ Time Frame: 12 weeks after treatment ]
    Difference in estimated Glomerular Filtration Rate (eGFR)/1,73 m2. Normal > 60 ml/min
  • Rejection episodes and graft loss [ Time Frame: 12 weeks after treatment ]
    Differences numbers of rejection episodes and graft loss In all suspected rejection episodes, a graft core biopsy will be done according to local practice prior to or at the latest within 24 hours after the initiation of anti-rejection therapy. A biopsy-proven acute rejection will be defined as a biopsy graded A1, A2, A3.
  • Inflammatory markers [ Time Frame: through the 12 weeks ]
    Differences in C-reactive protein. Normal value < 10mg/ml
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation
Official Title  ICMJE A Danish, Single Centre, Double-blind, Randomized Study Evaluating Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy to Reduce Primary Graft Dysfunction After Lung Transplantation
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 host immunological reaction towards the graft, and to reduce the ischemic reperfusion-injury after transplantation.
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 potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated to actively suppress the immune system and hereby evade recognition.

This knowledge will be transferred into studies in the ischemic reperfusion-injury/primary lung graft dysfunction in lung transplantation, and in suppressing the initial host immunological response towards the transplanted lung where a high degree of immunological and inflammatory activity is involved.

We will conduct a clinical trial in which patients receiving lung transplantation will be randomized to either placebo or treatment with allogeneic MSCs from adipose tissue. The aim is to assess the impact of MSCs on primary graft dysfunction.

The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems seen in the first period after lung transplantation and reduce the long-term graft rejection and dysfunction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind placebo-controlled dose titrating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE Lung Transplant Rejection
Intervention  ICMJE
  • Drug: adipose derived mesenchymal stromal cells
    Intravenous infusion of cells
    Other Name: CSCC_ASC
  • Drug: Saline
    Intravenous infusion of saline
Study Arms  ICMJE
  • Active Comparator: Infusion of 100 million ASC
    Infusion of 100 million adipose derived mesenchymal stromal cells from healthy donors
    Intervention: Drug: adipose derived mesenchymal stromal cells
  • Active Comparator: Infusion of 200 million ASC
    Infusion of 200 million adipose derived mesenchymal stromal cells from healthy donors
    Intervention: Drug: adipose derived mesenchymal stromal cells
  • Placebo Comparator: Infusion of placebo
    Infusion of saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2024
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jens Kastrup, MD Professor +4535452819 jens.kastrup@regionh.dk
Contact: Abbas A Qayuum, MD +4535452819 Abbas.Ali.Qayyum@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04714801
Other Study ID Numbers  ICMJE ASC Lungtransplantation
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We are open for collaboration with external research groups, but have no presently plans
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: When the study is finalized and published
Access Criteria: Relevant documented use of data.
Responsible Party JKastrup, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jens Kastrup, MD Professor Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP