Chronic Kidney DiseasesNCT06752577
Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
An observational study of Chronic Kidney Diseases and Kidney Transplant, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this protocol is to treat an intermediate-sized population with chronic kidney disease (CKD) including kidney transplant recipients. The protocol uses allogeneic bone marrow-derived mesenchymal stem cells (MSCs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Transplant
- What is being tested?
- Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2024to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients With Chronic Kidney Disease (CKD) or Kidney Transplant losing function
Who may be able to join
- Age >18 years
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
- Hemoglobin A1c ≤9%, if diabetes mellitus present
- If kidney transplant recipient, must have eGFR<60 mL/min/1.73m2 and evidence of progressive kidney function loss over ≥6 months
- Ability to give informed consent
Who cannot join
- Anemia (hemoglobin <8.5 g/dL)
- Body weight >150 kg or BMI >50
- Uncontrolled hypertension: sustained systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
- Chronic hypotension history: sustained SBP <85 mmHg
- Kidney failure requiring ongoing kidney replacement therapy including hemodialysis or peritoneal dialysis
- Active, high-dose immunosuppression therapy (e.g. chronic prednisone ≥20 mg daily)
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- Solid organ transplantation history; excluding kidney transplant
- Active treatment for acute cellular rejection, in kidney transplant recipients
- Recent cardiovascular event (hospitalization for myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 3 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
- History of liver cirrhosis
- Chronic obstructive pulmonary disease or asthma requiring daily medication
- History of recurring blood clotting disorder (thromboembolism: pulmonary embolism, deep venous thrombosis) requiring chronic anticoagulation therapy
- Pregnancy
- Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
- Active malignancy
- Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis; in kidney transplant recipients, active BK nephropathy)
- Recent COVID-19 infection, within the last 1 month
- History of hepatitis B or C (without cure), or HIV infection
- History of allergic reaction to cellular products (i.e. 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
- Anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mayo Clinic Regenerative Nephrology Program contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Donna K Lawson, 507-255-7975, lawson.donna3@mayo.edu
Regenerative Nephrology Program, regenerativenephrology@mayo.edu
About this study
The purpose of this protocol is to treat an intermediate-sized population with chronic kidney disease (CKD) including kidney transplant recipients. The protocol uses allogeneic bone marrow-derived mesenchymal stem cells (MSCs). MSC infusion may be delivered 1) intravenous or 2) intravenous plus intra-arterial to both kidneys. Individuals will have subsequent follow up for safety evaluations. Repeat dosing is allowed.
- Conditions
- Chronic Kidney Diseases, Kidney Transplant
- Being tested
- Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)
- Keywords
- stem cells, regenerative medicine, mesenchymal stromal cells, kidney disease, kidney failure, diabetic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)Drug
- intravenous infusion or 2) combined intravenous plus intra-arterial (to kidney) infusion of cells. Total dose: 200x10^6 MSC (administered over 15 minutes to 2 hours). Repeat dosing allowed at 6 month intervals.
| Study group | Role | What they receive |
|---|---|---|
| MSC | Individuals with chronic kidney disease (including a kidney transplant that is losing function) will receive allogeneic, bone marrow-derived mesenchymal stem cells (MSC). Two administration routes will be used. Repeat dosing is allowed. Receives: Drug: Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC) |
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 cell (MSC) intervention
Measured: 6 months after each MSC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start22 Dec 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ossium Health, Inc.
- Responsible party
- Principal investigator, LaTonya J. Hickson, Mayo Clinic
- Investigators
- LaTonya J Hickson, MD, Principal investigator, Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752577
- Sponsor's protocol ID
- 24-011356
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hickson LJ, Eirin A, Lerman LO. Challenges and opportunities for stem cell therapy in patients with chronic kidney disease. Kidney Int. 2016 Apr;89(4):767-78. doi: 10.1016/j.kint.2015.11.023. Epub 2016 Jan 26.
PubMed 26924058Hickson LJ, Herrmann SM, McNicholas BA, Griffin MD. Progress toward the Clinical Application of Mesenchymal Stromal Cells and Other Disease-Modulating Regenerative Therapies: Examples from the Field of Nephrology. Kidney360. 2021 Mar;2(3):542-557. doi: 10.34067/KID.0005692020.
PubMed 34316720Patel 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Vertebral Bone Marrow-derived Mesenchymal Stem Cells (BM-MSC) in Real World Scenarios of Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06752577
- Acronym / sponsor ID
- 24-011356
- Conditions
- Chronic Kidney Diseases, Kidney Transplant
- Keywords
- stem cells, regenerative medicine, mesenchymal stromal cells, kidney disease, kidney failure, diabetic kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Ossium Health, Inc.
- Study start
- 22 Dec 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 30 Dec 2024 (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 protocol is to treat an intermediate-sized population with chronic kidney disease (CKD) including kidney transplant recipients. The protocol uses allogeneic bone marrow-derived mesenchymal stem cells (MSCs). MSC infusion may be delivered 1) intravenous or 2) intravenous plus intra-arterial to both kidneys. Individuals will have subsequent follow up for safety evaluations. Repeat dosing is allowed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC | – | Drug: Allogeneic, vertebral bone marrow-derived mesenchymal stem cells (MSC)Individuals with chronic kidney disease (including a kidney transplant that is losing function) will receive allogeneic, bone marrow-derived mesenchymal stem cells (MSC). Two administration routes will be used. Repeat dosing is allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With Chronic Kidney Disease (CKD) or Kidney Transplant losing function
Key inclusion criteria (5 listed)
- Age >18 years
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2
- Hemoglobin A1c ≤9%, if diabetes mellitus present
- If kidney transplant recipient, must have eGFR<60 mL/min/1.73m2 and evidence of progressive kidney function loss over ≥6 months
- Ability to give informed consent
Key exclusion criteria (24 listed)
- Anemia (hemoglobin <8.5 g/dL)
- Body weight >150 kg or BMI >50
- Uncontrolled hypertension: sustained systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
- Chronic hypotension history: sustained SBP <85 mmHg
- Kidney failure requiring ongoing kidney replacement therapy including hemodialysis or peritoneal dialysis
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, vertebral bone marrow-derived mesenchymal stem cells (MSC)1) intravenous infusion or 2) combined intravenous plus intra-arterial (to kidney) infusion of cells. Total dose: 200x10^6 MSC (administered over 15 minutes to 2 hours). Repeat dosing allowed at 6 month intervals. | Drug | MSC |
Primary outcome
Adverse events and/or serious adverse events
Time frame: 6 months after each MSC infusion
Number of adverse events and/or serious adverse events associated with mesenchymal stem cell (MSC) intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 26924058Hickson LJ, Eirin A, Lerman LO. Challenges and opportunities for stem cell therapy in patients with chronic kidney disease. Kidney Int. 2016 Apr;89(4):767-78. doi: 10.1016/j.kint.2015.11.023. Epub 2016 Jan 26.
- Background: PubMed 34316720Hickson LJ, Herrmann SM, McNicholas BA, Griffin MD. Progress toward the Clinical Application of Mesenchymal Stromal Cells and Other Disease-Modulating Regenerative Therapies: Examples from the Field of Nephrology. Kidney360. 2021 Mar;2(3):542-557. doi: 10.34067/KID.0005692020.
- 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Mayo Clinic Regenerative Nephrology Program contact
LaTonya J Hickson, MD principal investigator
Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and 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 5 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 28 Jan 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna K Lawson (507-255-7975, lawson.donna3@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and/or serious adverse events (time frame: 6 months after each MSC infusion). 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 NCT06752577, which also lists 4 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 28 Jan 2026.