Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease

• ClinicalTrials.gov Identifier: NCT05362786
• Recruitment Status: Not yet recruiting
• First Posted: May 5, 2022
• Last Update Posted: June 14, 2022
• Sponsor: LaTonya J. Hickson
• Information provided by (Responsible Party): LaTonya J. Hickson, Mayo Clinic

Study Description

Brief Summary:

The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Chronic Kidney Disease
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dose Arm 1; Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in two intravenous infusions of 100x10^6 cells at time zero and three months	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC); Two intravenous infusions delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 100x10^6 cells at day 0 and day 84
Experimental: Dose Arm 2; Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10^6 cells	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC); Single intravenous infusion delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 200x10^6 cells at day 0

Outcome Measures

Primary Outcome Measures :

1. Adverse events and/or serious adverse events [ Time Frame: 15 months ]
   Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention
2. Change in eGFR Value [ Time Frame: 6 months ]
   Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min)

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age 30-80 years

2. Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m2

   1. If eGFR 45-55 ml/min/1.73m2, then albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
   2. If eGFR 25-44 ml/min/1.73m2, must have urine albumin:creatinine ratio ≥30mg/g despite maximally tolerated dose of RAAS drugs (e.g. ACE Inhibitors, Angiotensin Receptor Blockers)
3. Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
4. Ability to give informed consent

Exclusion Criteria:

1. Anemia (hemoglobin <9 g/dL)
2. Body weight >150 kg or BMI >50
3. Uncontrolled hypertension: sustained systolic blood pressure (SBP) >150 mmHg or diastolic blood pressure (DBP) ≥100 mmHg despite maximal doses of at least 2 different classes of anti-hypertensive medications
4. Chronic hypotension history: sustained SBP <85 mmHg
5. Glomerulonephritis not in partial or complete remission for 6 months (or estimated/ measured proteinuria greater than 10 grams/day),
6. Active glomerulonephritis (glomerular diseases with evidence of active urinary sediment, serology or biopsy findings) including ANCA-associated glomerulonephritis, post-infectious glomerulonephritis, lupus nephritis, amyloidosis, or other monoclonal gammopathy of renal significance
7. Autosomal dominant or recessive polycystic kidney disease
8. Nephrotic syndrome defined as proteinuria >3.5 g per 24 hours, plus hypoalbuminemia (serum albumin less than or equal to 2.5 g/L) and edema.
9. Proteinuria >5 g/day (with or without nephrotic syndrome).
10. Kidney failure requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation)
11. Active immunosuppression therapy (including prednisone greater than or equal to 10 mg daily)
12. Kidney transplantation history
13. Solid organ transplantation history
14. Recent cardiovascular event (myocardial infarction, stroke, congestive heart failure (NYHA class ≥III or ejection fraction ≤30%) within 6 months or uncontrolled cardiac arrhythmias (e.g. ventricular arrhythmia, supraventricular tachycardia and bradyarrhythmia)
15. History of liver cirrhosis
16. Chronic obstructive pulmonary disease or asthma requiring daily medication
17. History of blood clotting disorder (thromboembolism; pulmonary embolism, deep venous thrombosis)
18. Pregnancy
19. Unwilling to use contraception for at least 2 months after MSC infusion if sexually active and able to become pregnant or father a child.
20. Active malignancy
21. Active infection (e.g. systemic or specific organ involvement such as pneumonia or osteomyelitis)
22. Recent COVID-19 infection within the last 3 months
23. History of hepatitis B or C (without cure), or HIV infection
24. History of allergic reaction to cellular products (ie. blood transfusions, platelets)
25. Active tobacco use
26. Illicit drug use and excessive alcohol use
27. 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
28. Subjects anticipating prolonged travel or other physical restrictions that would prohibit return for scheduled study visits.
29. Inability to give informed consent

Contacts and Locations

Locations

United States, Florida

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224

United States, Minnesota

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

LaTonya J. Hickson

Investigators

• Principal Investigator: LaTonya Hickson, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: LaTonya J. Hickson, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05362786
• Other Study ID Numbers: 21-011822
• First Posted: May 5, 2022
• Last Update Posted: June 14, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency