Stem Cell Therapy for Chronic Kidney Disease

Recruiting at 1 trial location

Overseen By Latonya Hickson

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LaTonya J. Hickson

Must be taking: RAAS inhibitors

Must not be taking: Immunosuppressants, others

Disqualifiers: Diabetes, Hypertension, Obesity, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3 months

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using donor stem cells is safe and tolerable for people with chronic kidney disease. The stem cells might help repair their damaged kidneys. Stem cell therapy has shown potential in treating kidney diseases and aiding in kidney regeneration.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on active immunosuppression therapy, you may not be eligible to participate.

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

Research shows that mesenchymal stem cells (MSCs) from adipose tissue can help reduce kidney damage and improve kidney function in animal models of chronic kidney disease. These cells have anti-inflammatory properties and can modulate the immune response, which may be beneficial in treating kidney diseases. ^{1 2 3 4 5}

Is stem cell therapy safe for chronic kidney disease?

Research shows that low doses of adipose-derived mesenchymal stem cells (MSCs) are generally well-tolerated in animal models, but high doses can cause severe kidney damage. In humans, there have been cases where MSC therapy worsened kidney function in chronic kidney disease patients, indicating potential risks. ^{2 5 6 7 8}

How is the stem cell treatment for chronic kidney disease different from other treatments?

This treatment uses allogeneic adipose-derived mesenchymal stem cells (MSCs), which are known for their ability to reduce inflammation and modulate the immune system, potentially offering a novel approach to improve kidney function in chronic kidney disease. Unlike traditional treatments, this therapy involves either a single or two infusions of MSCs, which may help repair kidney damage and improve overall kidney health. ^{1 2 3 4 9}

Research Team

LaTonya Hickson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 30-80 with chronic kidney disease, specifically those not on dialysis or with a transplant history. Participants must have certain levels of kidney function and protein in their urine, and can't be pregnant, heavy smokers, drug users, or have uncontrolled diseases like severe anemia.

Inclusion Criteria

Ability to give informed consent

I am between 30 and 80 years old.

Your kidney function, as measured by eGFR, is between 25 and 55 ml/min/1.73m^2.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I currently have an infection.

I have liver cirrhosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogeneic adipose tissue-derived mesenchymal stem cells in intravenous infusions

3 months

2 visits (in-person) for Dose Arm 1, 1 visit (in-person) for Dose Arm 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

19 months

Treatment Details

Interventions

• Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion
• Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions

Trial Overview The study tests the safety of using stem cells from fat tissue to treat chronic kidney disease. Patients will receive either one or two infusions of these cells to see how well they tolerate them and any potential benefits.

Participant Groups

Group I: Dose Arm 2 Experimental Treatment 1 Intervention

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.

Group II: Dose Arm 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

LaTonya J. Hickson

Lead Sponsor

Trials

2

Recruited

20+

Findings from Research

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]

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 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-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]

In a study involving 285 patients, co-infusion of donor adipose-derived mesenchymal stem cells (AD-MSC) and hematopoietic stem cells (HSC) during kidney transplantation was found to be safe and effective in minimizing immunosuppression, with the best outcomes observed in the group receiving both cell types.

At 1 and 5 years post-transplant, the group receiving AD-MSC + HSC showed the highest patient and graft survival rates, along with fewer rejection episodes and lower immunosuppression requirements compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-infusion of donor adipose tissue-derived mesenchymal and hematopoietic stem cells helps safe minimization of immunosuppression in renal transplantation - single center experience. Vanikar, AV., Trivedi, HL., Kumar, A., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

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

2. Iran pubmed.ncbi.nlm.nih.gov

Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety. [2022]

3. 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]

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

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

5. 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]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dosing Limitation for Intra-Renal Arterial Infusion of Mesenchymal Stromal Cells. [2022]

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

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

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Co-infusion of donor adipose tissue-derived mesenchymal and hematopoietic stem cells helps safe minimization of immunosuppression in renal transplantation - single center experience. [2022]