Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury

Launched by HOPE BIOSCIENCES · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a potential new treatment for acute kidney injury (AKI), which can happen after a trauma, like a serious injury or burn. Researchers want to see if using specially developed stem cells from fat tissue (called Hope Biosciences Adipose-derived Mesenchymal Stem Cells or HB-adMSCs) can help prevent the worsening of kidney damage. The trial is in its early stages and is not yet recruiting participants.

To be eligible for this study, participants must be between 18 and 75 years old, have been diagnosed with a specific level of AKI within 10 days of an injury, and have received certain types of medical treatment related to their trauma. It’s important that the participant is expected to survive at least 24 hours after diagnosis. However, individuals with certain conditions, like chronic kidney disease or active cancer, as well as pregnant women, will not be eligible. If someone joins the study, they can expect to receive either the stem cell treatment or a placebo (which is like a sugar pill with no active ingredients) to compare how well the treatment works. As with any clinical trial, participants will be closely monitored for their safety and health throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between 18 and 75 years old AND
• • 2. Diagnosed with Modified KDIGO Stage 2 or 3 AKI within the first 10 days after injury AND
• • 3. Admitted to Intensive Care Unit (ICU) or Intermediate Medical Unit (IMU) AND
• • 4. Received at least 3 units of any blood product in any hour before nursing unit arrival after admission for trauma OR 20% or greater total burn surface area OR any electrical burn OR any crush injury AND
• • 5. Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 or 3 AKI AND
• • 6. Patient or patient's LAR has voluntarily signed the informed consent
• Exclusion Criteria:
• Patients are ineligible if they meet ONE OR MORE of the following:
• • 1. Incarcerated individuals.
• • 2. Pregnant and lactating females. It is unknown how stem cells affect a developing fetus or if they can be found in milk. To protect the safety of developing fetuses and breastfeeding children, pregnant and lactating women will be excluded.
• • 3. TBI deemed non-survivable by the trauma or neurosurgery attending physician.
• • 4. Hemodynamically unstable and requiring vasopressors for blood pressure support (systolic blood pressure \[SBP\] ≥90 mmHg) during the 30-minute period prior to IP thawing/preparation.
• • 5. Chronic kidney disease (CKD) or acute renal failure. Patients who are unable to communicate their pre-existing conditions will be excluded by Medical Alert bracelets/IDs, the presence of dialysis access (for either peritoneal dialysis or hemodialysis, in the form of a PD catheter, HD catheter, graft or fistula), kidney transplant or incisions consistent with organ transplantation, or eGFR \< 30 mL/min based on nadir creatinine obtained during the hospitalization and off dialysis. Patients who need renal replacement therapy within 12 hours of presentation will also be excluded.
• • 6. Pre-existing chronic liver disease as defined by Childs-Pugh-Turcotte of B or greater from the time of hospital presentation.
• • 7. Direct genitourinary trauma \> grade 2 (penetrating or blunt injury to the kidney) determined by standard of care CT scan or direct visualization during laparotomy
• • 8. Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
• • 9. Active malignancy.
• • 10. Known allergy to dimethyl sulfoxide or human serum albumin
• • 11. No available intravenous (IV) access (peripheral or central) of at least 22-gauge needle that can be utilized exclusively for IP during the time of planned infusion.
• • 12. Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
• • 13. Known Do Not Resuscitate (DNR) prior to randomization.