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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05362786
Recruitment Status : Not yet recruiting
First Posted : May 5, 2022
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
LaTonya J. Hickson, Mayo Clinic

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362786


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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency