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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05362786
• Other study ID #: 21-011822
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
LaTonya J. Hickson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and/or serious adverse events	Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention	15 months
Primary	Change in eGFR Value	Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min)	6 months