BridgeMD
Compares treatment options for Acute Kidney Injury
Official title Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
ClinicalTrials.gov ID: NCT06654193
What this study is testing
What is Allogeneic HB-adMSCs?
Allogeneic HB-adMSCs is an investigational medicine, being studied as a potential treatment for acute kidney injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Between 18 and 75 years old AND
- Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND
- Admitted to Intensive Care Unit or Intermediate Medical Unit AND
- Received at least 3 units of any blood product within 6 hours of admission for trauma OR 15% or greater burn area OR any electrical burn OR any crush...
- Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND
You likely can't join if
- Patients are ineligible if they meet ONE OR MORE of the following:
- Incarcerated individuals
- Pregnant and lactating females
- TBI deemed non-survivable by the trauma or neurosurgery attending physician
- Hemodynamically unstable and requiring vasopressors for blood pressure support (systolic blood pressure ≥90 mmHg) during the 30-minute period prior...
- Pre-existing chronic kidney disease or acute kidney failure.
See the full eligibility criteria
- Between 18 and 75 years old AND
- Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND
- Admitted to Intensive Care Unit or Intermediate Medical Unit AND
- Received at least 3 units of any blood product within 6 hours of admission for trauma OR 15% or greater burn area OR any electrical burn OR any crush injury AND
- Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND
- Patient or patient's Legally Authorized Representative (LAR) has voluntarily signed the informed consent.
- Patients are ineligible if they meet ONE OR MORE of the following:
- Incarcerated individuals
- Pregnant and lactating females
- TBI deemed non-survivable by the trauma or neurosurgery attending physician
- Hemodynamically unstable and requiring vasopressors for blood pressure support (systolic blood pressure ≥90 mmHg) during the 30-minute period prior to investigational product (IP) thawing/preparation
- Pre-existing chronic kidney disease or acute kidney failure.
- Pre-existing chronic liver disease.
- Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
- Active malignancy.
- Known allergy to dimethyl sulfoxide or human serum albumin.
- No available intravenous access (peripheral or central) of at least 22-gauge needle that can be utilized exclusively for IP during the time of planned infusion.
- Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
- Known Do Not Resuscitate (DNR) prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.