Stem cell shot aims to heal kidneys fast
NCT ID NCT06954740
First seen Jun 26, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study tests whether Amimestrocel, a stem cell therapy from umbilical cords, can help people with acute kidney injury. Fifty adults aged 18 to 75 will receive the cells through an IV on four days. Researchers will check kidney function and safety over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amimestrocel (stem cells from umbilical cord)
- What this could lead to
- If it works, this could point toward a new treatment to help kidneys recover faster after acute injury.
- What could go wrong
- This is an early Phase 2 trial with only 50 people, so results may not apply broadly. Stem cell treatments can have unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 18 and 75 years old; gender is not restricted. 2. According to the 2023 KDIGO diagnostic criteria for acute kidney injury (AKI), including those that occur during the course of the disease in various patients with chronic kidney disease (CKD), AKI can be diagnosed if any of the following conditions is met: ① The serum creatinine level increases by ≥ 26.5 μmol/L within 48 hours; ② The serum creatinine level increases by more than 1.5 times or higher than the baseline value within 7 days; ③ The urine output decreases (\< 0.5 mL/kg/h) and persists for more than 6 hours; The baseline value of serum creatinine: The lowest creatinine value obtained in the outpatient department or ward within 3 months, and the longest time limit is the creatinine value within 1 year. If there is no such value, the serum creatinine can be estimated using the MDRD equation under the assumption that the baseline eGFR is 75 ml/min/1.73m². 3. .Ability to give informed consent. Exclusion Criteria: 1. Post-renal AKI. 2. Acute kidney injury caused by glomerular diseases such as rapidly progressive glomerulonephritis, lupus nephritis, anti-neutrophil cytoplasmic antibody-associated nephritis, anti-glomerular basement membrane antibody-mediated nephritis, vasculitis, cryoglobulinemia, thrombotic microangiopathy, etc. 3. Hemodynamic instability. 4. Severe cardiovascular diseases. 5. Severe pulmonary dysfunction. 6. A history of intracerebral hemorrhage or cerebral infarction within the past six months. 7. Subjects with abnormal laboratory indicators: AST or ALT \> 5 × upper limit of normal value (ULN); total bilirubin \> 3 × ULN; white blood cell count \< 2000/μL (2 × 10⁹/L), hemoglobin \< 6 g/dL (60 g/L), neutrophils \< 1000/μL (1 × 10⁹/L), platelets \< 50000/μL (50 × 10⁹/L). 8. Uncontrollable infection. 9. Patients with active hepatitis B or hepatitis C virus infection, active tuberculosis, severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc. 10. Received systemic immunosuppressants or glucocorticoid treatment for more than one week within 30 days before enrollment. 11. Have received hemodialysis or peritoneal dialysis treatment. 12. Have a history of hematopoietic stem cell transplantation or solid organ transplantation. 13. Patients with a history of malignant tumor within the past 5 years. 14. Life expectancy is less than 1 month. 15. Those with a known history of severe allergy to component blood or blood products, or those with a history of allergy to heterologous proteins. 16. Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a fertility plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures. 17. Patients who participated in other interventional clinical trials within 1 month before enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, China
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Beijing hospital
RECRUITINGBeijing, Beijing Municipality, 100010, China
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Capital Medical University Affiliated Beijing Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, 100050, China
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China-Japan Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, 100029, China
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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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- ICU kidney injury: does the pattern predict lasting damage?
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- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?