What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include medications to manage symptoms and complications, dialysis, and kidney transplantation. For therapies similar to Allogeneic Mesenchymal Stem/Stromal Cell Therapy, which are still under investigation, potential side effects may include immune reactions, infections, and complications related to the administration procedure. General side effects of CKD treatments can include nausea, fatigue, electrolyte imbalances, and increased risk of infections due to immunosuppressive medications.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD), primarily focusing on managing symptoms and slowing disease progression. These include medications like angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to control blood pressure and reduce proteinuria. Additionally, sodium-glucose co-transporter-2 (SGLT2) inhibitors have been approved for their renal protective effects. While specific FDA approvals for regenerative and immunomodulatory therapies like Allogeneic Mesenchymal Stem/Stromal Cell Therapy are still under investigation, these therapies hold promise for future treatment options by potentially repairing kidney tissue and modulating immune responses.

What other types of research exist?

Promising novel alternatives to allogeneic mesenchymal stem/stromal cell therapy for chronic kidney disease patients include: 1) Induced pluripotent stem cell (iPSC)-derived therapies, which offer the potential for patient-specific treatments with reduced risk of immune rejection. 2) Exosome-based therapies, which utilize the regenerative and immunomodulatory properties of exosomes derived from stem cells. 3) Gene editing technologies, such as CRISPR-Cas9, to correct genetic defects or enhance regenerative capabilities of cells. 4) Bioengineered kidney tissues or organoids, which aim to replace or support damaged kidney function. These alternatives are in various stages of research and development and may offer new hope for CKD patients in the near future.

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Mesenchymal Stem Cell Therapy

Stem Cell Therapy for Chronic Kidney Disease

Phase 1

Waitlist Available

Led By LaTonya Hickson, MD

Research Sponsored by LaTonya J. Hickson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 30-80 years

Be older than 18 years old

Must not have

Inability to give informed consent

Active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 22 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, immune system responses against the infused cells, general discomforts such as fever or fatigue. Since it's a new treatment being tested for safety, close monitoring for unexpected side effects is part of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

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I currently have an infection.

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I have liver cirrhosis.

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I haven't had a heart attack, stroke, or severe heart failure in the last 6 months and don't have uncontrolled heart rhythm problems.

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My kidney inflammation hasn't improved in 6 months or my protein loss in urine is very high.

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I have a history of blood clotting disorders.

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I do not have active hepatitis B, C, or HIV.

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I currently have cancer.

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My weight is over 150 kg or my BMI is over 50.

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I have a diagnosed kidney condition such as lupus nephritis or amyloidosis.

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I am on dialysis or have had a kidney transplant due to kidney failure.

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I have had an organ transplant.

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I have chronic obstructive pulmonary disease or asthma.

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I have a genetic form of polycystic kidney disease.

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I am on strong medication to suppress my immune system.

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I have severe swelling, very low blood protein levels, and lose a lot of protein in my urine.

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I have had a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 22 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~22 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events and/or serious adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Arm 2Experimental Treatment1 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 1Experimental Treatment1 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.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Allogeneic mesenchymal stem/stromal cell (MSC) therapy leverages the regenerative and immunomodulatory properties of MSCs to treat Chronic Kidney Disease (CKD). MSCs can differentiate into various cell types, promoting tissue repair and regeneration. Additionally, they modulate the immune response, reducing inflammation and preventing further kidney damage. These mechanisms are crucial for CKD patients as they address both the structural damage and the inflammatory processes that contribute to disease progression, potentially improving kidney function and slowing the progression to end-stage renal disease.

Therapies Targeting Epigenetic Alterations in Acute Kidney Injury-to-Chronic Kidney Disease Transition.Cell-based therapies for experimental chronic kidney disease: a systematic review and meta-analysis.