Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation

NCT ID: NCT04714801

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-11-30

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.

Conditions

Lung Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Infusion of 100 million ASC

Infusion of 100 million adipose derived mesenchymal stromal cells from healthy donors

Group Type: ACTIVE_COMPARATOR

adipose derived mesenchymal stromal cells

Intervention Type: DRUG

Intravenous infusion of cells

Infusion of 200 million ASC

Infusion of 200 million adipose derived mesenchymal stromal cells from healthy donors

Group Type: ACTIVE_COMPARATOR

adipose derived mesenchymal stromal cells

Intervention Type: DRUG

Intravenous infusion of cells

Infusion of placebo

Infusion of saline

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Intravenous infusion of saline

Interventions

adipose derived mesenchymal stromal cells

Intravenous infusion of cells

Intervention Type: DRUG

Saline

Intravenous infusion of saline

Intervention Type: DRUG

Other Intervention Names

CSCC_ASC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

JKastrup

MD professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Kastrup, MD Professor

Role: STUDY_DIRECTOR

Rigshospitalet, Denmark

Michael Perch, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jens Kastrup, MD Professor

Role: CONTACT

jens.kastrup@regionh.dk

+4535452819

Abbas A Qayuum, MD

Role: CONTACT

Abbas.Ali.Qayyum@regionh.dk

+4535452819

Facility Contacts

Jens Kastrup, MD DMSc

Role: primary

jens.kastrup@regionh.dk

+4535452817

References

Qayyum AA, Lund TK, Jensen PB, Jensen K, Haack-Sorensen M, Ekblond A, Norgaard MJ, Moller-Sorensen H, Mathiasen AB, Moller CH, Rorvig SB, Kalhauge A, Bruunsgaard H, Litman T, Johansen EM, Hojgaard LD, Kastrup J, Perch M. Allogeneic mesenchymal stromal cell therapy on primary graft dysfunction after lung transplantation. JHLT Open. 2025 Mar 20;8:100254. doi: 10.1016/j.jhlto.2025.100254. eCollection 2025 May.

Reference Type: DERIVED

PMID: 40247997 (View on PubMed)

Other Identifiers

ASC Lungtransplantation

Identifier Type: -

Identifier Source: org_study_id