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An open, single-center, phase 1 study to evaluate safety of hypoxic preconditioned allogeneic bone marrow derived mesenchymal stem cell aiming to prevent acute kidney injury due to renal ischemia-reperfusion injury

An open, single-center, phase 1 study to evaluate safety of hypoxic preconditioned allogeneic bone marrow derived mesenchymal stem cell aiming to prevent acute kidney injury due to renal ischemia-reperfusion injury

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0003417
Enrollment
10
Registered
2019-01-09
Start date
2019-08-02
Completion date
Unknown
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : Temporary partial blocking of kidney blood flow against kidney tumor Patients who are undergoing kidney excisional surgery and are at risk of acute kidney injury after

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients =18 and <80 years of age who temporarily block the blood flow of the kidney and undergo partial renal resection for kidney tumors 2) A patient with a primary renal tumor with a diameter of 2 cm or less, clinical stage T1aN0M0 (without surrounding tissue or lymph node involvement or metastasis)

Exclusion criteria

Exclusion criteria: 1) Patients with a history of blood diseases (malignant blood diseases: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma) 2) Serum AST / ALT level >3 × upper limit of normal 3) Patients with a history of hypersensitivity against a gentamycin 4) Patients positive for pathogenic microorganisms (HIV, HBV, HCV, Syphilis) 5) Patients unable to compliance with protocol and follow-up 6) Patients with a history of substance abuse in the past year 7) Those who participated in other clinical trials in the past 30 days before registration. 8) Patients to be inappropriate to participate in the study according to the investigator 9) Uncontrolled hypertension or hypotension (systolic blood pressure >170 or 100 or <50 mmHg) 10) Those who being treated for severe infectious disease 11) Pregnant women, lactating women and those who disagree with contraception 12) Those who suffered or sufferring another malignant tumors excluding primary kidney tumors 13) Patients with a single kidney 14) patients with chronic kidney disease V (glomerular filtration rate <15 ml / min per 1.73 m² or during dialysis)

Design outcomes

Primary

MeasureTime frame
Adverse event;Laboratory test;Vital sign;Physical examination

Secondary

MeasureTime frame
Serum creatinine;Computed tomography and DTPA (Diethylene Tetramine Penta-Acetic acid) scan

Countries

Korea, Republic of

Contacts

Public ContactDalsan You

Asan Medical Center

dalsanyou@amc.seoul.kr+82-2-3010-3979

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026