None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : KDSTEM Inj. (Urine Derived Stem Cells, 3 x 10^8 cells/30mL/6 syringes) mixed with 70mL of Saline Solution will be injected intravenously for 3 times over a span of 2wee
Sponsors
EHLcell Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female aged between 19 and 80 2. Diabetic nephropathy with an eGFR of 15~59 mL/min/1.73 m2 (MDRD) at the screening. 3. Male or Female of childbearing age agreed to use accurate birth control method during this clinical trial. 4. Subjects voluntarily singed an agreement in writing for this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Subjects who meet any of the following conditions at the screening visit 1) Systemic infection 2). HIV, HBV, HCV, Syphilis (+) 3) Blood pressure higher than 190mmHg of SBP or 110mmHg of DBP 4). AST or ALT higher than 3 times the upper limit of normal values 2. Subjects who received hemodialysis within 12 weeks prior to the screening or will be receive hemodialysis during this clinical trial 3. Subjects who received kidney transplantation or will be receive kidney transplantation during this clinical trial 4. Subjects diagnosed with the following diseases 1) Solid Tumors or Hematologic Malignancies within 5 years prior to the screening 2) Alzheimer's disease or mental illness. 3) Alcohol or drug abuse 4) Severe Respiratory disease (Chronic Obstructive Pulmonary Disease, asthma, pneumonia, pulmonary embolism and pneumothorax, etc.) 5. Subjects who received cell therapy or another clinical trial product/device within 4 weeks prior to the screening 6. Subjects who were hypersensitivity reaction pertaining to penicillin, streptomycin, and amphotericin B 7. Subjects, as determined by an investigator, receiving treatment anticipated to affect the results of the clinical trials 8. Subjects being pregnant, providing breast milk, resulted in positive pregnancy test at screening or planning for pregnancy during this clinical trial 9. Those who do not have at least three time points (eGFR, BUN, sCr, uACR) data within the last six months. 10. etc. Subjects determined unsuitable for this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| The variation in eGFR, BUN, Serum creatinine, UPCR, UACR,Urine protein, HbA1c;The variation in Soluble Alpha Klitho(a-Klotho) | — |
Countries
Korea, Republic of
Contacts
Public ContactJEONG DAYOUNG
EHLcell Clinic
Outcome results
None listed