MSC Therapy for Chronic Kidney Disease

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LaTonya J. Hickson

Must be taking: RAAS drugs

Must not be taking: Immunosuppressants

Disqualifiers: Anemia, Hypertension, Glomerulonephritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing the safety of injecting special cells called mesenchymal stem cells into the bloodstream of patients with long-term kidney disease. The goal is to see if these cells can help repair and heal damaged kidneys. The study will use two different doses to find the best approach. Mesenchymal stem cells (MSCs) have been investigated in numerous studies for their potential to repair kidney injury and improve renal function.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should be on the maximally tolerated dose of certain medications for kidney disease and diabetes, suggesting you may need to continue those.

Is MSC therapy safe for humans?

Studies show that adipose-derived mesenchymal stem cell (MSC) therapy is generally safe, with no significant cellular or renal toxicity observed in short-term studies. However, there is a report of potential kidney damage in a chronic kidney disease patient after autologous MSC therapy, highlighting the need for caution. ^{1 2 3 4 5}

How is the treatment with allogeneic adipose-derived mesenchymal stem cells different from other treatments for chronic kidney disease?

This treatment is unique because it uses stem cells from fat tissue, which have anti-inflammatory properties and can help repair kidney damage, unlike traditional treatments that mainly focus on managing symptoms. It offers a new approach by potentially regenerating kidney tissue and improving kidney function. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Allogeneic adipose-derived mesenchymal stem cells (MSC) for chronic kidney disease?

Research shows that adipose-derived mesenchymal stem cells (MSCs) can reduce kidney damage and improve kidney function in animal models of chronic kidney disease. These cells have anti-inflammatory properties and can help modulate the immune response, which may be beneficial in treating kidney diseases. ^{2 6 9 10 11}

Who Is on the Research Team?

LaTonya Hickson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Ability to give informed consent

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in one of two dosing regimens: two intravenous infusions of 100x10^6 cells at time zero and three months, or a single intravenous infusion of 200x10^6 cells

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and changes in eGFR

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Allogeneic adipose-derived mesenchymal stem cells (MSC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Arm 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

LaTonya J. Hickson

Lead Sponsor

Trials

2

Recruited

20+

Published Research Related to This Trial

A single intravenous infusion of adipose-derived mesenchymal stem cells (Ad-MSCs) significantly improved kidney structure and function in mice with acute kidney injury induced by cisplatin, leading to better survival rates.

The treatment resulted in reduced inflammation and fibrosis, as indicated by decreased levels of inflammatory markers (TNF-α and TGF-β1) and improved kidney tissue morphology, demonstrating the potential of Ad-MSCs as a therapeutic strategy for kidney regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Renal Parenchyma in Response to Allogeneic Adipose-Derived Mesenchymal Stem Cells Transplantation in Acute Kidney Injury. Begum, S., Ahmed, N., Mubarak, M., et al.[2022]

In a rat model of chronic kidney disease (CKD), adipose tissue-derived mesenchymal stem cells (AD-MSCs) significantly reduced plasma creatinine levels and markers of kidney damage, indicating improved renal function.

AD-MSCs also enhanced the expression of proteins associated with kidney regeneration, such as Pax-2, BMP-7, and VEGF, suggesting their potential as a therapeutic option for CKD due to their availability and less invasive collection method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cells derived from adipose tissue reduce functional and tissue damage in a rat model of chronic renal failure. Villanueva, S., Carreño, JE., Salazar, L., et al.[2022]

Adipose tissue-derived mesenchymal stem cells (MSCs) maintain their anti-inflammatory and immune-modulating properties even in the presence of human kidney disease or uremic serum, suggesting they could be effective in treating kidney conditions.

The potential for using autologous (patient-derived) adipose tissue-derived MSCs in clinical settings highlights the need for further research to establish their long-term safety and efficacy in kidney disease treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose tissue-derived mesenchymal stem cells: a fat chance of curing kidney disease? Lin, F.[2023]

In a dose escalation study involving 21 subjects, adipose-derived human mesenchymal stem cell (MSC) therapy showed no significant cellular or renal toxicity, indicating a favorable safety profile.

The therapy led to improvements in renal oxygenation and glomerular filtration rate, along with a reduction in inflammatory markers, suggesting potential efficacy in treating renovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving human kidney function in renovascular disease with mesenchymal stem cell therapy. Sivanathan, KN., Coates, PT.[2020]

Adipose-derived mesenchymal stem cells (AD-MSC) significantly protect against kidney injury caused by 45 minutes of renal ischemia followed by 48 hours of reperfusion in rats, as evidenced by improved serum creatinine and blood urea nitrogen levels.

Histological analysis revealed that AD-MSC treatment reduced tubular necrosis and other signs of kidney damage, indicating their potential as a therapeutic intervention for acute kidney injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of adipose-derived mesenchymal stem cells on renal function and histopathology in a rat model of ischemia-reperfusion induced acute kidney injury. Changizi-Ashtiyani, S., Hafazeh, L., Ghasemi, F., et al.[2022]

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Modulation of Renal Parenchyma in Response to Allogeneic Adipose-Derived Mesenchymal Stem Cells Transplantation in Acute Kidney Injury. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Role of adipose tissue-derived stem cells in the progression of renal disease. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Bone marrow-mesenchymal stromal cell infusion in patients with chronic kidney disease: A safety study with 18 months of follow-up. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cells derived from adipose tissue reduce functional and tissue damage in a rat model of chronic renal failure. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Adipose tissue-derived mesenchymal stem cells: a fat chance of curing kidney disease? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Improving human kidney function in renovascular disease with mesenchymal stem cell therapy. [2020]

7. Iran pubmed.ncbi.nlm.nih.gov

The effect of adipose-derived mesenchymal stem cells on renal function and histopathology in a rat model of ischemia-reperfusion induced acute kidney injury. [2022]

8. Iran pubmed.ncbi.nlm.nih.gov

Stem Cell Therapy Ameliorates Ischemia-reperfusion Induced Kidney Injury After 24 Hours Reperfusion. [2020]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Rapid deterioration of preexisting renal insufficiency after autologous mesenchymal stem cell therapy. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cells are a rescue approach for recovery of deteriorating kidney function. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Therapeutic potential of stromal cells of non-renal or renal origin in experimental chronic kidney disease. [2019]