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Mesenchymal Stem Cell Therapy
MSC Therapy for Chronic Kidney Disease
Phase 1
Waitlist Available
Led By LaTonya Hickson, MD
Research Sponsored by LaTonya J. Hickson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Summary
This trial is testing if it is safe to give patients with kidney disease stem cells through IV. There are two groups getting different doses at different times.
Who is the study for?
Adults aged 30-80 with chronic kidney disease, having specific levels of kidney function and protein in urine despite certain medications, can join. They must be able to consent and not have severe anemia, recent heart issues, liver cirrhosis, or a history of significant infections like hepatitis B/C or HIV. Pregnant individuals or those unwilling to use contraception post-treatment are excluded.Check my eligibility
What is being tested?
The trial is testing the safety of injecting mesenchymal stem cells from fat tissue into patients with chronic kidney disease at two different doses and times. The goal is to see if these cells can help improve kidney function without causing harm.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, allergic responses due to cellular products similar to blood transfusions, fatigue, fever, headaches or nausea. Since this is a test for safety and tolerability, close monitoring will occur for any other unexpected effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events and/or serious adverse events
Change in eGFR Value
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Arm 2Experimental Treatment1 Intervention
Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10^6 cells
Group II: Dose Arm 1Experimental Treatment1 Intervention
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Kidney Disease (CKD) include antihypertensive medications, which manage blood pressure to prevent further kidney damage, and immunosuppressive therapies, which reduce inflammation and immune-mediated damage. Mesenchymal Stem Cells (MSCs) offer a novel approach due to their regenerative and immunomodulatory properties.
MSCs can differentiate into various cell types to repair damaged kidney tissues and modulate immune responses to reduce inflammation. These mechanisms are crucial for CKD patients as they address both the structural damage and the inflammatory processes that exacerbate kidney disease, potentially improving kidney function and slowing disease progression.
Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis.
Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis.
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Who is running the clinical trial?
LaTonya J. HicksonLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
LaTonya Hickson, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
20 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level is less than 9 grams per deciliter.You weigh more than 150 kilograms or your BMI is over 50.You had a serious heart problem or uncontrolled irregular heartbeats in the last 6 months.You have had liver cirrhosis in the past.You had COVID-19 in the past 3 months.You have had hepatitis B or C, or HIV, and it has not been cured.You have had an allergic reaction to blood transfusions or platelets in the past.You are currently smoking or using tobacco products.You use illegal drugs or drink too much alcohol.You have a high level of protein in your urine, more than 5 grams per day.You need kidney treatment like dialysis or a kidney transplant.You have had a solid organ transplant in the past.If your kidney function is a little low, and you have high levels of protein in your urine despite taking the highest dose of certain kidney medications, you may not be able to participate.If your kidney function is between 25-44 ml/min/1.73m2, you must have high levels of protein in your urine even after taking the highest tolerated dose of certain medications for your kidneys.Your average blood sugar level (Hemoglobin A1c) is less than or equal to 8% even with the highest dose of your diabetes medication.You are currently taking medication that weakens your immune system.You must be between 30 and 80 years old.Your kidney function, measured by eGFR, is between 25 and 55 ml/min/1.73m2.You have a history of long-term low blood pressure with a systolic blood pressure consistently below 85 mmHg.You have a history of blood clotting disorders such as pulmonary embolism or deep venous thrombosis.Your blood pressure is consistently high, even with maximum doses of at least 2 different types of blood pressure medications.You have certain kidney diseases that are currently causing problems, like ANCA-associated glomerulonephritis or lupus nephritis.You have a specific genetic condition called polycystic kidney disease.You have had a kidney transplant in the past.You have chronic obstructive pulmonary disease or asthma that needs daily medication.You currently have cancer.You have a current infection, like pneumonia or osteomyelitis.You have a kidney condition called glomerulonephritis that is not under control, or you have very high levels of protein in your urine.You have a kidney condition with a lot of protein in your urine, low levels of albumin in your blood, and swelling.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Arm 1
- Group 2: Dose Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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