Chronic Kidney DiseasesPhase 1NCT04869761
Stem Cell Therapy for Chronic Kidney Disease
A Phase 1 study testing Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion and Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by LaTonya J. Hickson at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion and Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2021to 26 Apr 2023
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80 years.
- Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2
- Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
- Ability to give informed consent.
Who cannot join
- Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
- Anemia (hemoglobin less than 9g/dL)
- Body weight greater than 150 kg or BMI greater than 50
- Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)
- Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
- Glomerulonephritis not in partial or complete remission for 6 months (or estimated/measured proteinuria greater than 10 grams/day)
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- Active glomerulonephritis (glomerular disease) include: ANCA associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance.
- Nephrotic syndrome defined as proteinuria greater than 3.5g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5g/L) and edema
- Autosomal dominant or recessive polycystic kidney disease
- Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
- Active immunosuppression therapy (including prednisone greater than or equal to 10mg daily)
- Kidney transplantation history
- Solid organ transplantation history
- Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure) within 6 months or uncontrolled cardiac arrhythmias
- Liver cirrhosis
- Chronic obstructive pulmonary disease, asthma
- History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
- Pregnancy
- Active malignancy
- Active infection
- Active hepatitis B or C, or HIV infection
- History of allergic reaction to cellular products (ie. blood transfusions, platelets)
- Active tobacco use
- Illicit drug use and excessive alcohol use presence of psychosocial issues (e.g., uncontrolled mental illness, unpredictable childcare or eldercare responsibilities, irregular/inflexible work schedule) that may interfere with the ability to complete all study procedures
- Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits
- Inability or unwilling to have magnetic resonance imaging (MRI) or computed tomography (CT) studies
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Diabetic Nephropathies
- Being tested
- Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion, Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions
- Keywords
- Stem cell, mesenchymal stem cell, mesenchymal stromal cell, diabetes mellitus, diabetic nephropathy, diabetic kidney disease, kidney, GFR
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single InfusionDrug
Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery
Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two InfusionsDrug
Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery
| Study group | Role | What they receive |
|---|---|---|
| Dose Arm 1 | Experimental | Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells at day 0 and month 3. Receives: Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions |
| Dose Arm 2 | Experimental | Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10^6 cells at day 0. Receives: Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and/or serious adverse events
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start7 Oct 2021
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- LaTonya J. Hickson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LaTonya J. Hickson, Mayo Clinic
- Investigators
- LaTonya Hickson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869761
- Sponsor's protocol ID
- 20-008380
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2021
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.
PubMed 40333016Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.
PubMed 40009460
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study
- ClinicalTrials.gov ID
- NCT04869761
- Acronym / sponsor ID
- 20-008380
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus, Diabetic Nephropathies
- Keywords
- Stem cell, mesenchymal stem cell, mesenchymal stromal cell, diabetes mellitus, diabetic nephropathy, diabetic kidney disease, kidney, GFR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- LaTonya J. HicksonUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 3 May 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.
The purpose of this study is to assess the safety and tolerability of allogeneic mesenchymal stem / stromal cell therapy in individuals with chronic kidney disease.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Arm 1 | Experimental | Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two InfusionsSubjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells at day 0 and month 3. |
| Dose Arm 2 | Experimental | Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single InfusionSubjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10^6 cells at day 0. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-80 years.
- Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m^2
- Spot urine albumin:creatinine ≥30 mg/g unless on Renin-angiotensin-aldosterone system (RAAS) inhibition.
- Ability to give informed consent.
Key exclusion criteria (27 listed)
- Hemoglobin A1c greater than or equal to 11%.(in individuals with diabetes mellitus)
- Anemia (hemoglobin less than 9g/dL)
- Body weight greater than 150 kg or BMI greater than 50
- Uncontrolled hypertension: sustained systolic blood pressure (SBP) greater than 155 mmHg at screening exam (a maximum of 3 screening visits will be allowed for demonstration of blood pressure control)
- Chronic hypotension: sustained SBP less than 85 mmHg at screening exam.
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 cells (MSC)-Single InfusionSingle MSC infusion of 150x10^6 cells at time zero; intravenous delivery | Drug | Dose Arm 2 |
| Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two InfusionsTwo MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery | Drug | Dose Arm 1 |
Primary outcome
Adverse events and/or serious adverse events
Time frame: 22 months
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
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 6 Jun 2025.
- Derived from this study: PubMed 40333016Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available.
- Derived from this study: PubMed 40009460Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.
- 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.
LaTonya Hickson, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion and Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by LaTonya J. Hickson at 2 sites 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 4 inclusion and 27 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adverse events and/or serious adverse events (time frame: 22 months). 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 NCT04869761, which also lists 2 linked publications.
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 6 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.