Lung Transplant RejectionPhase 1/2NCT04714801
Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation
A Phase 1/2 study testing adipose derived mesenchymal stromal cells and Saline in people with Lung Transplant Rejection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- adipose derived mesenchymal stromal cells and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 30 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, 2100
Jens Kastrup, MD DMSc, +4535452817, jens.kastrup@regionh.dk
Jens Kastrup, MD DMSc
About this study
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
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.
Read the 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
- Being tested
- adipose derived mesenchymal stromal cells, Saline
- Keywords
- lung transplantation, Rejection, mesenchymal stromal cell, immune modulation, clinical trial, treatment
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose derived mesenchymal stromal cellsDrug
Also called CSCC_ASC
Intravenous infusion of cells
SalineDrug
Intravenous infusion of saline
| Study group | Role | What they receive |
|---|---|---|
| Infusion of 100 million ASC | Active comparator | Infusion of 100 million adipose derived mesenchymal stromal cells from healthy donors Receives: 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 Receives: Drug: adipose derived mesenchymal stromal cells |
| Infusion of placebo | Placebo comparator | Infusion of saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days after treatment
Secondary outcomes (2)
Kidney glomerular Filtration Rate
Difference in estimated Glomerular Filtration Rate (eGFR)/1,73 m2. Normal > 60 ml/min
Measured: 12 weeks after treatment
Inflammatory markers
Differences in C-reactive protein. Normal value < 10mg/ml
Measured: through the 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo-controlled dose titrating study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JKastrup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jens Kastrup, MD Professor, Study director, Copenhagen University Hospital, RigshospitaletMichael Perch, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714801
- Sponsor's protocol ID
- ASC Lungtransplantation
- Status last verified
- Jul 2021
- First submitted
- 29 May 2020
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are open for collaboration with external research groups, but have no presently plans
Publications
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.
PubMed 40247997
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04714801
- Acronym / sponsor ID
- ASC Lungtransplantation
- Conditions
- Lung Transplant Rejection
- Keywords
- lung transplantation, Rejection, mesenchymal stromal cell, immune modulation, clinical trial, treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind placebo-controlled dose titrating study
| Arm | Type | Receives |
|---|---|---|
| Infusion of 100 million ASC | Active comparator | Drug: adipose derived mesenchymal stromal cellsInfusion of 100 million adipose derived mesenchymal stromal cells from healthy donors |
| Infusion of 200 million ASC | Active comparator | Drug: adipose derived mesenchymal stromal cellsInfusion of 200 million adipose derived mesenchymal stromal cells from healthy donors |
| Infusion of placebo | Placebo comparator | Drug: SalineInfusion of saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose derived mesenchymal stromal cellsAlso: CSCC_ASCIntravenous infusion of cells | Drug | Infusion of 100 million ASC, Infusion of 200 million ASC |
| SalineIntravenous infusion of saline | Drug | Infusion of placebo |
Primary outcome
Pulmonary graft dysfunction (PDG)
Time frame: 3 days after treatment
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
2 secondary outcomes
Kidney glomerular Filtration Rate
Time frame: 12 weeks after treatment
Inflammatory markers
Time frame: through the 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 40247997Qayyum 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.
- Individual participant dataSharing planned: Yes. We are open for collaboration with external research groups, but have no presently plans
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Kastrup, MD Professor study director
Copenhagen University Hospital, Rigshospitalet
Michael Perch, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adipose derived mesenchymal stromal cells and Saline in people with Lung Transplant Rejection, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Kastrup, MD Professor (+4535452819, jens.kastrup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary graft dysfunction (PDG) (time frame: 3 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.