Ischemia Reperfusion InjuryPhase 1NCT04388761
Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
A Phase 1 study testing Allogeneic adipose derived mesenchymal stem cells in people with Ischemia Reperfusion Injury, run by Tambi Jarmi.
Trial summary
The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- Allogeneic adipose derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Feb 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female kidney transplant candidates age 18 and above.
- Patient is receiving kidney allograft from deceased donor with KDPI>85%.
- Ability of subject to give appropriate consent.
- Females of childbearing potential with agreement to use birth control for six months post-transplant.
- Approved by the Mayo Clinic Transplant Selection Committee.
- Signed Authorization for Donation of Anatomical Gifts on file.
Who cannot join
- Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
- Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
- Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
- Patients with previous history of bone marrow transplant.
About this study
The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- Allogeneic adipose derived mesenchymal stem cells
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose derived mesenchymal stem cellsDrug
Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
| Study group | Role | What they receive |
|---|---|---|
| Intra parenchymal injection | Experimental | 5 subjects will receive AMSCs via direct injection into the kidney parenchyma only Receives: Drug: Allogeneic adipose derived mesenchymal stem cells |
| Intra-arterial infusion | Experimental | 5 subjects will receive AMSCs via intra-arterial infusion only Receives: Drug: Allogeneic adipose derived mesenchymal stem cells |
| Intra parenchymal injection & Intra-arterial infusion | Experimental | 5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion Receives: Drug: Allogeneic adipose derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events (SAEs)
Number of serious adverse events reported. SAEs will include delayed graft function (30 days post-transplant), difficult to control bleeding (intraoperative), sub-scapular kidney hematoma or arteriovenous fistula formation (24 hours postop), and development of stroke, myocardial infarction, or pulmonary embolism (1 year post-transplant).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startSep 2020 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Challenges in recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tambi Jarmi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tambi Jarmi, Mayo Clinic
- Investigators
- Tambi Jarmi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388761
- Sponsor's protocol ID
- 20-000264
- Status last verified
- Oct 2023
- First submitted
- 12 May 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
- ClinicalTrials.gov ID
- NCT04388761
- Acronym / sponsor ID
- 20-000264
- Conditions
- Ischemia Reperfusion Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Challenges in recruiting participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tambi JarmiUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 14 May 2020 (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.
The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra parenchymal injection | Experimental | Drug: Allogeneic adipose derived mesenchymal stem cells5 subjects will receive AMSCs via direct injection into the kidney parenchyma only |
| Intra-arterial infusion | Experimental | Drug: Allogeneic adipose derived mesenchymal stem cells5 subjects will receive AMSCs via intra-arterial infusion only |
| Intra parenchymal injection & Intra-arterial infusion | Experimental | Drug: Allogeneic adipose derived mesenchymal stem cells5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female kidney transplant candidates age 18 and above.
- Patient is receiving kidney allograft from deceased donor with KDPI>85%.
- Ability of subject to give appropriate consent.
- Females of childbearing potential with agreement to use birth control for six months post-transplant.
- Approved by the Mayo Clinic Transplant Selection Committee.
Key exclusion criteria (4 listed)
- Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
- Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
- Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
- Patients with previous history of bone marrow transplant.
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 |
|---|---|---|
| Allogeneic adipose derived mesenchymal stem cellsInjection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft | Drug | Intra parenchymal injection, Intra parenchymal injection & Intra-arterial infusion, Intra-arterial infusion |
Primary outcome
Serious Adverse Events (SAEs)
Time frame: 1 year
Number of serious adverse events reported. SAEs will include delayed graft function (30 days post-transplant), difficult to control bleeding (intraoperative), sub-scapular kidney hematoma or arteriovenous fistula formation (24 hours postop), and development of stroke, myocardial infarction, or pulmonary embolism (1 year post-transplant).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tambi Jarmi, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic adipose derived mesenchymal stem cells in people with Ischemia Reperfusion Injury, run by Tambi Jarmi.
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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (SAEs) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2023.