Stem Cells for Acute Kidney Injury

(AKI Trial)

Not yet recruiting at 4 trial locations

Overseen By Charles S Cox, Jr., MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Hope Biosciences

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Chronic kidney disease, Active malignancy, others

Compensation: Varies

Number of Visits: 3

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the use of special stem cells, called Allogeneic HB-adMSCs, to prevent serious kidney damage in individuals who have experienced a traumatic injury. The trial compares the effects of these stem cells to a placebo, a harmless saline solution, to determine if the stem cells can prevent further kidney deterioration. Suitable participants have been diagnosed with a serious type of sudden kidney damage (known as AKI) within 10 days of an injury and are in an intensive care unit. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

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

Research has shown that a type of stem cell therapy called allogeneic HB-adMSCs has been tested for safety in people. In earlier studies, patients received these stem cells without experiencing major side effects. For instance, one study found that these stem cells did not cause harmful effects, though they also did not show clear improvements in kidney function.

This trial is in the early stages (Phase 1/2), focusing primarily on ensuring the treatment's safety. Early-stage trials typically involve close monitoring for any side effects. So far, results appear promising regarding safety, but further research is needed to confirm how well patients can tolerate this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute kidney injury, which often involve supportive care like dialysis or medication to manage symptoms, allogeneic HB-adMSCs offer a novel approach by using stem cells derived from adipose (fat) tissue. These stem cells have the unique ability to potentially promote healing and reduce inflammation directly in the kidneys. Researchers are excited about this treatment because it could address the underlying damage rather than just alleviating symptoms, potentially speeding up recovery and improving outcomes for patients with acute kidney injury.

What evidence suggests that Allogeneic HB-adMSCs might be an effective treatment for Acute Kidney Injury?

Research has shown that a type of stem cell therapy called allogeneic HB-adMSCs, which participants in this trial may receive, might help treat acute kidney injury (AKI). In animal studies, these stem cells have shown promise in improving kidney function and speeding up recovery. For instance, a study in cats with kidney injury found that stem cell treatments led to quick recovery. These cells likely help by reducing inflammation and aiding in kidney repair. Although more research is needed in humans, early results offer hope for those with AKI. ^{1 2 3 6 7}

Who Is on the Research Team?

Charles S Cox, Jr., MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Allogeneic adipose-derived HB-adMSCs

Group II: Placebo Placebo Group 1 Intervention

Normal saline

Who Is Running the Clinical Trial?

Hope Biosciences

Lead Sponsor

Trials

27

Recruited

470+

Hope Biosciences LLC

Lead Sponsor

Hope Biosciences Research Foundation

Lead Sponsor

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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-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. clinicaltrials.gov clinicaltrials.gov/study/NCT04362189

Efficacy and Safety Study of Allogeneic HB-adMSCs for the ... Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06654193

UCSF Acute Kidney Injury Trial → Allogeneic HB-adMSCs vs ... This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/549715

Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute ... This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of ...

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-022-03039-z

Rapid recovery of male cats with postrenal acute kidney injury ... In this study, we investigated the therapeutic efficacy of allogeneic adipose mesenchymal stem cell-derived extracellular vesicles (ADMSCEVs) on cat models of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0034528816301230

Efficacy of allogeneic mesenchymal stem cell ... A described model was used to induce acute kidney injury in cats. Fat and bone marrow derived MSCs were tested to reduce acute kidney injury.

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

Safety and efficacy of intravenous infusion of allogeneic ... Administration of aMSCs cultured from cryopreserved adipose was not associated with adverse effects, but was also not associated with improvement in renal ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04362189/efficacy-and-safety-study-of-allogeneic-hb-admscs-for-the-treatment-of-covid-19

Efficacy and Safety Study of Allogeneic HB-adMSCs for the ... Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells ...