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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

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.

Condition or disease Intervention/treatment Phase
Lung Transplant Rejection Drug: adipose derived mesenchymal stromal cells Drug: Saline Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: 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
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Infusion of 100 million ASC
Infusion of 100 million adipose derived mesenchymal stromal cells from healthy donors
Drug: adipose derived mesenchymal stromal cells
Intravenous infusion of cells
Other Name: CSCC_ASC

Active Comparator: Infusion of 200 million ASC
Infusion of 200 million adipose derived mesenchymal stromal cells from healthy donors
Drug: adipose derived mesenchymal stromal cells
Intravenous infusion of cells
Other Name: CSCC_ASC

Placebo Comparator: Infusion of placebo
Infusion of saline
Drug: Saline
Intravenous infusion of saline




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Glomerular Filtration Rate [ Time Frame: 12 weeks after treatment ]
    Difference in estimated Glomerular Filtration Rate (eGFR)/1,73 m2. Normal > 60 ml/min

  2. 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.


  3. Inflammatory markers [ Time Frame: through the 12 weeks ]
    Differences in C-reactive protein. Normal value < 10mg/ml



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714801


Contacts
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Contact: Jens Kastrup, MD Professor +4535452819 jens.kastrup@regionh.dk
Contact: Abbas A Qayuum, MD +4535452819 Abbas.Ali.Qayyum@regionh.dk

Locations
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Denmark
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Jens Kastrup, MD DMSc    +4535452817    jens.kastrup@regionh.dk   
Principal Investigator: Jens Kastrup, MD DMSc         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Jens Kastrup, MD Professor Rigshospitalet, Denmark
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Responsible Party: JKastrup, MD professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04714801    
Other Study ID Numbers: ASC Lungtransplantation
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
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
Informed Consent Form (ICF)
Time Frame: When the study is finalized and published
Access Criteria: Relevant documented use of data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JKastrup, Rigshospitalet, Denmark:
lung transplantation
Rejection
mesenchymal stromal cell
immune modulation
clinical trial
treatment