Stem Cell Therapy for Chronic Kidney Disease

Sponsor

LaTonya J. Hickson (Other)

Overall Status

Recruiting

CT.gov ID

NCT04869761

Collaborator

(none)

Enrollment

Locations

Arms

66.8

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus Diabetic Nephropathies	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Allogeneic Mesenchymal Stem Cell Therapy in Patients With Chronic Kidney Disease: A Phase I Study

Actual Study Start Date :

Oct 7, 2021

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Arm 1 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.	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery
Experimental: Dose Arm 2 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.	Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery

Arm

Intervention/Treatment

Experimental: Dose Arm 1

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.

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions

Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery

Experimental: Dose Arm 2

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.

Drug: Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion

Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery

Outcome Measures

Primary Outcome Measures

Adverse events and/or serious adverse events [22 months]
Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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)
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