70 Participants Needed

Stem Cells for Acute Kidney Injury

(AKI Trial)

Recruiting at 4 trial locations
CS
Overseen ByCharles S Cox, Jr., MD

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications that suppress the immune system, you may not be eligible to participate.

What data supports the effectiveness of the treatment Allogeneic HB-adMSCs for acute kidney injury?

Research shows that adipose-derived mesenchymal stem cells (AD-MSCs) can protect kidneys from damage and improve kidney function in animal models of acute kidney injury. These stem cells help by reducing harmful inflammation and stress in the kidneys.12345

Is the use of adipose-derived mesenchymal stem cells safe for treating kidney injuries?

Research on adipose-derived mesenchymal stem cells (ADMSCs) in animal models, like rats, shows they can protect kidneys from damage and improve kidney function without indicating harmful effects. These studies suggest ADMSCs are generally safe for use in treating kidney injuries.13467

How is the treatment Allogeneic HB-adMSCs different from other treatments for acute kidney injury?

Allogeneic HB-adMSCs (adipose-derived mesenchymal stem cells) are unique because they use stem cells from fat tissue to help repair kidney damage, potentially offering a regenerative approach that other treatments do not provide. This treatment focuses on reducing kidney injury and improving function by modulating the kidney's response to damage, which is different from standard treatments that may only manage symptoms.12358

What is the purpose of this trial?

This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) to prevent progression of trauma-induced Acute Kidney Injury (AKI).

Research Team

CS

Charles S Cox, Jr., MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with trauma-induced Acute Kidney Injury (AKI). Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.

Inclusion Criteria

Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI
Patient or patient's legally authorized representative (LAR) has voluntarily signed the informed consent
I was diagnosed with moderate kidney injury within 10 days after it happened.
See 2 more

Exclusion Criteria

Known Do Not Resuscitate (DNR) prior to randomization
Known allergy to dimethyl sulfoxide or human serum albumin
Pregnant and lactating females due to unknown effects of stem cells on developing fetus or milk
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 3 infusions of allogeneic adipose-derived MSCs or placebo daily for 3 days

3 days
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for infusion-related adverse events and progression of AKI

1 year

Long-term follow-up

Participants are monitored for long-term outcomes such as mortality, recurrent AKI, and post-injury organ dysfunction

1 year

Treatment Details

Interventions

  • Allogeneic HB-adMSCs
Trial Overview The study is testing the safety and effectiveness of Allogeneic HB-adMSCs, which are stem cells derived from adipose tissue, compared to a placebo (normal saline) in preventing the progression of AKI following trauma.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Allogeneic adipose-derived HB-adMSCs
Group II: PlaceboPlacebo Group1 Intervention
Normal saline

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hope Biosciences

Lead Sponsor

Trials
27
Recruited
470+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Findings from Research

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.
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]
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.
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 study involving male Wistar rats with chronic kidney injury induced by adenine, treatment with human adipose tissue-derived stem cells (hADSCs) significantly reduced kidney fibrosis and improved kidney function as indicated by lower serum and urine levels of urea and creatinine.
The hADSC therapy also decreased the expression of several fibrotic and inflammatory markers in the kidneys, suggesting a mechanism by which these stem cells promote kidney repair and reduce damage.
Human adipose derived stem cells regress fibrosis in a chronic renal fibrotic model induced by adenine.Rivera-Valdés, JJ., García-Bañuelos, J., Salazar-Montes, A., et al.[2018]

References

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]
Modulation of Renal Parenchyma in Response to Allogeneic Adipose-Derived Mesenchymal Stem Cells Transplantation in Acute Kidney Injury. [2022]
Human adipose derived stem cells regress fibrosis in a chronic renal fibrotic model induced by adenine. [2018]
Adipose-derived mesenchymal stem cell protects kidneys against ischemia-reperfusion injury through suppressing oxidative stress and inflammatory reaction. [2022]
Effect of autologous adipose-derived stem cells in renal cold ischemia and reperfusion injury. [2013]
Long Term Study of Protective Mechanisms of Human Adipose Derived Mesenchymal Stem Cells on Cisplatin Induced Kidney injury in Sprague-Dawley Rats. [2020]
Can mobilization of bone marrow stem cells be an alternative regenerative therapy to stem cell injection in a rat model of chronic kidney disease? [2023]
Therapeutic Effect of Three-Dimensional Cultured Adipose-Derived Stem Cell-Conditioned Medium in Renal Ischemia-Reperfusion Injury. [2023]
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