Kidney TransplantPhase 1NCT05456243
Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients
A Phase 1 study testing Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) and High dose adipose tissue derived mesenchymal stromal cells (A-MSC) in people with Kidney Transplant, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the transplanted kidney and treat rejection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) and High dose adipose tissue derived mesenchymal stromal cells (A-MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 20 Apr 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and provide informed consent.
- Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.
- Clinical Inclusion Criteria:
- Stable renal function:
- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the serum creatine prior to the biopsy (must be within 3 months of the biopsy);
- Estimated eGFR > 30 ml/min by MDRD.
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- Histologic Criteria for Eligibility:
- ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular capillaritis (ptc) (g:1 or 2; ptc:1 or 2).
- Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2); intimal arteritis (v) (v: 1 or 2).
- Mixed ABMR and cellular rejection.
Who cannot join
- Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening.
- History of post-transplant intervention for obstructive uropathy
- One or more of the following laboratory values:
- o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT) ≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0, Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase their platelet count will not be excluded).
- One or more of the following parameters:
- o Temperature ≥ 38°C (100.4°F), Respiratory rate ≥ 20/min, Oxygen saturation (SpO2) ≤ 90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or > 140/min
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- Patients with the following grades/classes of vascular diseases:
- NYHA Class 3-4 CHF
- Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular response, supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled chronic atrial fibrillation will be allowed to participate.
- Cerebrovascular accident (CVA) within 90 days of screening
- Peripheral Arterial Disease (PAD), patients who have had prior vascular interventions for PAD in the index lower extremity.
- Acute illness within 30 days of screening.
- History of allergy or intolerance to iodinated contrast agents
- Women of childbearing potential or male subjects with female partners of childbearing potential unwilling to use an effective method of contraception during and for 12 months post-treatment.
- History of or current evidence of alcohol abuse, illicit drug use or dependence
- Active COVID 19 or positive test for the SARS-CoV-2 virus
- History of malignancy within 5 years of enrollment. History of adequately treated in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous cell) will be permitted
- Serologic evidence of human immunodeficiency virus 1 or 2 infection
- Epstein Barr Virus (EBV) sero-negativity (EBV naïve)
- Cytomegalovirus (CMV) sero-negativity
- Active post-transplant opportunistic infections at the time of screening (CMV, BK virus, polyoma virus, EBV)
- Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV IgG positive), or those with HBV surface antibody positive but HBV core antibody negative subjects will not be excluded from the study.
- Have received a kidney transplant from a Hepatitis C positive donor and plan to receive anti-viral treatment after transplant
- Any chronic condition for which anti-coagulation cannot be safely interrupted for kidney biopsy based on the CHA2DS2-VASc score of ≥ 6 risk stratum. If subjects fall into either the high or the moderate thrombotic risk, they will be deemed to be not safe to interrupt anticoagulation:
- High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months) stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6, CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within 3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or antithrombin; antiphospholipid antibodies; multiple abnormalities)
- Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve prosthesis and 1 or more of the of following risk factors: atrial fibrillation, prior stroke or transient ischemic attack, hypertension, diabetes, congestive heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6; Venous thromboembolism: VTE within the past 3 to 12 months, non-severe thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation), recurrent VTE
- For all other subjects, anticoagulation can be safely interrupted for 3 days prior to infusion and resumed a day after the infusion.
- Positive pregnancy test
- Participation in any other studies that involved investigational drugs or regimens in the preceding year
- Any other condition, in the investigator's judgment, that increases the risk of A-MSC infusion or prevents safe trial participation
- Unwilling or unable to adhere to study requirements and procedures
- Per Banff criteria category 6: the presence of other changes not considered to be caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury, Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or Drug-Induced Interstitial Nephritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)
This research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the transplanted kidney and treat rejection.
- Conditions
- Kidney Transplant
- Being tested
- Low dose adipose tissue derived mesenchymal stromal cells (A-MSC), High dose adipose tissue derived mesenchymal stromal cells (A-MSC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)Biological
Single intra-arterial infusion of 1 x 10^5 cells/kg
High dose adipose tissue derived mesenchymal stromal cells (A-MSC)Biological
Single intra-arterial infusion of 5 x 10^5 cells/kg infused over 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Group | Experimental | Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one low dose of allogeneic A-MSC. Receives: Biological: Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) |
| High Dose Group | Experimental | Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one high dose of allogeneic A-MSC. Receives: Biological: High dose adipose tissue derived mesenchymal stromal cells (A-MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening kidney allograft rejection
Number of subjects to have biopsy-proven worsening kidney allograft rejection
Measured: 28 days after A-MSC infusion
Adverse Events
Number of Grade 3 or higher AEs attributable to the A-MSC infusion including infusion reaction/cytokine release syndrome, per the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). Cytokine Release Syndrome (CRS) will be defined using the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cell
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 posted13 Jul 2022
- Study start30 Jan 2023
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timucin Taner, Mayo Clinic
- Investigators
- Timucin Taner, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456243
- Sponsor's protocol ID
- 21-012522
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2022
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intraarterial Infusion of Adipose Tissue-derived Mesenchymal Stromal Cells to Treat Antibody-mediated and Cellular Rejection in Adult Kidney Transplant Recipients (AMSCAR)
- ClinicalTrials.gov ID
- NCT05456243
- Acronym / sponsor ID
- 21-012522
- Conditions
- Kidney Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 13 Jul 2022 (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.
This research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the transplanted kidney and treat rejection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Group | Experimental | Biological: Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one low dose of allogeneic A-MSC. |
| High Dose Group | Experimental | Biological: High dose adipose tissue derived mesenchymal stromal cells (A-MSC)Adult kidney transplant recipients with subclinical rejection (biopsy-proven antibody-mediated and/or cellular rejection, including borderline rejection) will be administered one high dose of allogeneic A-MSC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to understand and provide informed consent.
- Have received a renal transplant (first or repeat), and the most recent protocol biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.
- Stable renal function:
- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the serum creatine prior to the biopsy (must be within 3 months of the biopsy);
- Estimated eGFR > 30 ml/min by MDRD.
Key exclusion criteria (32 listed)
- Nephrotic range proteinuria (≥ 3.5g/24h), detected more than once in the year preceding screening.
- History of post-transplant intervention for obstructive uropathy
- One or more of the following laboratory values:
- o Hemoglobin (Hb} ≤ 8 g/dL, Potassium (K) ≥ 5.5 mEq/dL, Alanine aminotransferase (ALT) ≥ 60 U/L, Hemoglobin A1C (HbA1c) ≥ 7%, International Normalized Ratio (INR) ≥ 2.0, Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase their platelet count will not be excluded).
- One or more of the following parameters:
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 |
|---|---|---|
| Low dose adipose tissue derived mesenchymal stromal cells (A-MSC)Single intra-arterial infusion of 1 x 10^5 cells/kg | Biological | Low Dose Group |
| High dose adipose tissue derived mesenchymal stromal cells (A-MSC)Single intra-arterial infusion of 5 x 10^5 cells/kg infused over 5 minutes | Biological | High Dose Group |
Primary outcome
Worsening kidney allograft rejection
Time frame: 28 days after A-MSC infusion
Number of subjects to have biopsy-proven worsening kidney allograft rejection
Adverse Events
Time frame: 1 year
Number of Grade 3 or higher AEs attributable to the A-MSC infusion including infusion reaction/cytokine release syndrome, per the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0). Cytokine Release Syndrome (CRS) will be defined using the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cell
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- 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.
Timucin Taner, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) and High dose adipose tissue derived mesenchymal stromal cells (A-MSC) in people with Kidney Transplant, run by Mayo Clinic at 1 site in United States.
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 10 inclusion and 32 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: finished, as of the sponsor's last update on 1 Jul 2026. 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 United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Worsening kidney allograft rejection (time frame: 28 days after A-MSC infusion). The study lists 2 primary outcomes in all. 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 1 Jul 2026.