Acute Kidney InjuryPhase 1/2AKINCT06654193
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
A Phase 1/2 study testing Allogeneic HB-adMSCs and Normal Saline in people with Acute Kidney Injury, run by Hope Biosciences LLC at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Allogeneic HB-adMSCs and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2026to 1 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Sabrina Goddard, MD
Sabrina Goddard, MD
- Recruiting
University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas, 77479
Charles S Cox, Jr., Dr., 713-500-7307, Charles.S.Cox@uth.tmc.edu
Charles S Cox, Jr., Dr.
- Not yet recruiting
University of California, San Francisco
San Francisco, California, 94143
Joseph Cuschieri, MD
Joseph Cuschieri, MD
About this study
Official title: Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
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).
Read the detailed description
This multicenter, prospective, randomized, double-blind, placebo-controlled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious.
Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
- Conditions
- Acute Kidney Injury
- Being tested
- Allogeneic HB-adMSCs, Normal Saline
- Keywords
- acute kidney injury, stem cells, aki, hope biosciences
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic HB-adMSCsDrug
Allogeneic HB-adMSCs
Normal SalineDrug
Sterile Saline Solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline Receives: Drug: Normal Saline |
| Treatment | Experimental | Allogeneic adipose-derived HB-adMSCs Receives: Drug: Allogeneic HB-adMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
Incidence of treatment-related adverse events (TEAEs) will be monitored to assess the safety of the infusion product on the patients in Phase 1 of the trial.
Measured: 1 year
Duration of Acute Kidney Injury (AKI) at Stage 2
Proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment
Measured: 2 days
Secondary outcomes (7)
Number of patients with progression of Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 AKI
The progression from Stage 2 to Stage 3 AKI often constitutes the initiation of renal replacement therapy (RRT), tripling of creatinine levels or creatinine > 4 mg/dL with an increase of 0.5 mg/dL, with an associated marked increase in morbidity, mortality, and cost.
Measured: 1 year
Mortality at 30, 90 days and 365 days
Whether the patient remains alive or not at 1 month, 3 months, and 1 year
Measured: 1 year
Post-injury organ dysfunction and thromboinflammation
Includes incidence of sepsis, acute respiratory distress syndrome (ARDS), venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)
Measured: 1 year
Number of participants with chronic critical illness (≥14 days)
Determined by prolonged intensive care unit (ICU) admission (≥14 days) with evidence of ongoing organ dysfunction
Measured: 1 year
Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)
Severity of each complication will be determined by complication-specific criteria, e.g. Berlin criteria (mild, moderate, severe)
Measured: 1 year
Hospital-, ICU- and ventilator-free days
Defined as the number of days a patient was not in the hospital or on the ventilator or in the ICU at 30 days or hospital discharge/death
Measured: 1 year
Number of patients with Recurrent AKI during the same hospitalization
Defined as the amount of patients who have several episodes of AKI in the same hospitalization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Feb 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicenter, prospective, randomized, double-blind, placebo controlled pragmatic Phase 1/Phase 2a clinical study will enroll severely injured trauma or burn patients who have developed Stage 2 AKI. Eligible patients will be randomized to receive Hope Biosciences (HB)-adMSCs or placebo administered within 24 hours of consent and in 3 doses, each 24 hours apart. The investigators will enroll 10 patients in Cohort 1, the Phase 1 safety substudy. All patients in Cohort 1 will receive active investigational product (IP). The investigators will enroll 60 patients in Cohort 2, the Phase 2a substudy; 30 patients will receive active IP, and 30 will receive placebo via randomization. The study population is trauma and burn patients admitted to participating hospitals who meet the inclusion and exclusion criteria. The study population will be reflective of the general trauma population at the participating sites.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hope Biosciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston, University of California, San Francisco, University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Charles S Cox, Jr., MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654193
- Sponsor's protocol ID
- HBAKI01
- Acronym
- AKI
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
- ClinicalTrials.gov ID
- NCT06654193
- Acronym / sponsor ID
- AKI / HBAKI01
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, stem cells, aki, hope biosciences
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hope Biosciences LLCIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center, Houston, University of California, San Francisco, University of Alabama at Birmingham
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This multicenter, prospective, randomized, double-blind, placebo-controlled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious.
Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This multicenter, prospective, randomized, double-blind, placebo controlled pragmatic Phase 1/Phase 2a clinical study will enroll severely injured trauma or burn patients who have developed Stage 2 AKI. Eligible patients will be randomized to receive Hope Biosciences (HB)-adMSCs or placebo administered within 24 hours of consent and in 3 doses, each 24 hours apart. The investigators will enroll 10 patients in Cohort 1, the Phase 1 safety substudy. All patients in Cohort 1 will receive active investigational product (IP). The investigators will enroll 60 patients in Cohort 2, the Phase 2a substudy; 30 patients will receive active IP, and 30 will receive placebo via randomization. The study population is trauma and burn patients admitted to participating hospitals who meet the inclusion and exclusion criteria. The study population will be reflective of the general trauma population at the participating sites.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal SalineNormal saline |
| Treatment | Experimental | Drug: Allogeneic HB-adMSCsAllogeneic adipose-derived HB-adMSCs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic HB-adMSCsAllogeneic HB-adMSCs | Drug | Treatment |
| Normal SalineSterile Saline Solution | Drug | Placebo |
Primary outcome
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
Time frame: 1 year
Incidence of treatment-related adverse events (TEAEs) will be monitored to assess the safety of the infusion product on the patients in Phase 1 of the trial.
Duration of Acute Kidney Injury (AKI) at Stage 2
Time frame: 2 days
Proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment
7 secondary outcomes
Number of patients with progression of Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 AKI
Time frame: 1 year
Mortality at 30, 90 days and 365 days
Time frame: 1 year
Post-injury organ dysfunction and thromboinflammation
Time frame: 1 year
Number of participants with chronic critical illness (≥14 days)
Time frame: 1 year
Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)
Time frame: 1 year
Hospital-, ICU- and ventilator-free days
Time frame: 1 year
Number of patients with Recurrent AKI during the same hospitalization
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles S Cox, Jr., MD principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic HB-adMSCs and Normal Saline in people with Acute Kidney Injury, run by Hope Biosciences LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles S Cox, Jr., MD (713-500-7307, Charles.S.Cox@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.