Stem Cell Therapy for Chronic Kidney Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a special type of stem cell therapy (allogeneic adipose-derived mesenchymal stem cells) is safe and tolerable for people with chronic kidney disease. Researchers use cells from donated fat tissue to determine if one or two infusions can make a difference. The trial targets individuals with specific levels of kidney function, excluding those already on dialysis or with other serious conditions. Those living with ongoing kidney problems might be suitable candidates to learn more about this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using stem cells from donated fat tissue have been well tolerated in previous studies. One study found that a single dose of these stem cells was safe for patients with moderate-to-severe chronic kidney disease (CKD), as it did not cause major side effects.

This treatment is in its early stages and is primarily being tested for safety. While early results suggest it is likely safe, there is still more to learn. It is important to remember that early trials focus on safety and do not yet reveal all possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for chronic kidney disease, which often involve medications to manage symptoms or dialysis to filter waste, the investigational treatment uses allogeneic adipose-derived mesenchymal stem cells (MSCs). These stem cells have the potential to repair and regenerate damaged kidney tissues, addressing the root cause of the disease rather than just alleviating symptoms. Researchers are particularly excited about two approaches: one involves a single high-dose infusion of MSCs, while the other uses two smaller infusions over time. Both methods aim to harness the regenerative capabilities of MSCs to offer a novel solution for chronic kidney disease.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research suggests that stem cells from fat tissue might aid long-term kidney problems. Some studies have shown that infusing these cells can improve kidney function markers, such as blood filtration efficiency and creatinine levels. In this trial, participants in Dose Arm 2 will receive a single infusion of allogeneic adipose-derived mesenchymal stem cells (MSC), which has shown small improvements in studies, though these may not be very noticeable. Participants in Dose Arm 1 will receive two infusions, which have demonstrated similar improvements and are generally safe and well-tolerated. Both single and double infusions have shown promise in animal and early human studies, indicating potential support for kidney health. ^{1 2 5 6 7}

Who Is on the Research Team?

LaTonya Hickson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6577210/

Adipose tissue-derived mesenchymal stromal cells for ... Findings from this pilot study demonstrate that intravenous infusion of autologous expanded AT-MSCs into CKD patients was not associated with adverse effects.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04869761

Stem Cell Therapy for Chronic Kidney Disease Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3707049/

Safety and efficacy of intravenous infusion of allogeneic ... These studies produced evidence of modest, but unlikely to be clinically significant, improvement in renal function but also showed evidence of significant ...

4. frontiersin.org frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2025.1632324/full

Case Report: Allogeneic adipose-derived mesenchymal ... This case report suggests that allogeneic AD-MSCs have potential therapeutic efficacy in felines with end-stage CKD, offering a new possibility for the ...

5. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04029-y

Immunomodulatory effects of mesenchymal stem cell ... MSC infusion can improve renal function indices such as glomerular filtration rate, urine protein, serum creatinine, and blood urea nitrogen, while inhibiting ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9097837/

Allogeneic adipose tissue‐derived stem cells ELIXCYTE® ... This phase I trial demonstrated single‐dose intravenous ELIXCYTE was well tolerated in moderate‐to‐severe CKD patients and its preliminary ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05362786

NCT05362786 | Bone Marrow-Derived Mesenchymal Stem ... 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 ...