Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation

NCT04714801 | Unknown Phase 1 DMC

• 1 other identifier: ASC Lungtransplantation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Rejection

Keywords

lung transplantation; Rejection; mesenchymal stromal cell; immune modulation; clinical trial; treatment

Outcome Measures

Primary Outcomes (1)

• Pulmonary graft dysfunction (PDG)

  Difference in presence or not presence 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 presence of both pulmonary infiltrates and hypoxemia occurring within the first 72 hours after transplantation

  3 days after treatment

Secondary Outcomes (2)

• Kidney glomerular Filtration Rate

  12 weeks after treatment

• Inflammatory markers

  through the 12 weeks

Study Arms (3)

Infusion of 100 million ASC

ACTIVE COMPARATOR

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

Drug: adipose derived mesenchymal stromal cells

Infusion of 200 million ASC

ACTIVE COMPARATOR

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

Drug: adipose derived mesenchymal stromal cells

Infusion of placebo

PLACEBO COMPARATOR

Infusion of saline

Drug: Saline

Interventions

adipose derived mesenchymal stromal cells DRUG

Intravenous infusion of cells

Also known as: CSCC_ASC

Infusion of 100 million ASC; Infusion of 200 million ASC

Saline DRUG

Intravenous infusion of saline

Infusion of placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40247997 DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jens Kastrup, MD Professor

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Michael Perch, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Kastrup, MD Professor

CONTACT

+4535452819; jens.kastrup@regionh.dk

Abbas A Qayuum, MD

CONTACT

+4535452819; Abbas.Ali.Qayyum@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD professor

Model Details: Double-blind placebo-controlled dose titrating study

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: January 19, 2021
• Study Start: October 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: When the study is finalized and published
• Access Criteria: Relevant documented use of data.

Locations

DK (1)