Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease

NCT05042206 | Completed Phase 1

• 1 other identifier: PMC-P-12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is an open, single-center, phase 1 clinical trial to evaluate the safety of allogeneic bone marrow-derived mesenchymal stem cell injection in patients with chronic kidney disease. The purpose is to evaluate the safety for 12 months after administration of Cellgram-CKD 3 times in 10 patients with chronic kidney disease.

Conditions

Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse event, and the level of the adverse event (AE) analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0)

  The primary endpoint is an adverse event, and the level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0).

  Adverse events are collected from the first administration of the investigational product to 12 months after the third administration of the investigational product.

Secondary Outcomes (3)

• Changes in eGFR

  1, 3, 6, 9, and 12 months of administration of the investigational product

• Changes in BUN

  1, 3, 6, 9, and 12 months of administration of the investigational product

• Changes in Creatinine

  1, 3, 6, 9, and 12 months of administration of the investigational product

Study Arms (1)

Cellgram-CKD

EXPERIMENTAL

Subjects receive a safety evaluation at 1 month, 3 months, 6 months, 9 months and 12 months after intravenous infusion of Cellgram-CKD 10mL at intervals of 2 weeks (14 days) 3 times. In the case of Cellgram-CKD, a milky white cell suspension solution is filled in a colorless and transparent plastic syringe, and the syringe tip is fixed with an obturator.

Biological: Cellgram-CKD

Interventions

Cellgram-CKD BIOLOGICAL

Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease

Cellgram-CKD

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 19 and 79
• Those diagnosed with CKD stage 3b or 4 \[eGFR 15 - 44 ml/min/1.73 m2\] within 1 year before screening
• Those who voluntarily participated in the clinical trial and signed the Informed consent form

You may not qualify if:

• Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
• Those with the following medical history/comorbidities A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive disorder, dementia or psychiatric disorder D. Alcohol or drug abuse E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) F. Stroke G. Systemic autoimmune disease
• Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure \>190 mmHg or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg or diastolic blood pressure \<50 mmHg) C. AST and ALT ≥ upper limit of normal x 3.0 D. Total bilirubin ≥ upper limit of normal x 1.5
• At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening
• Those with a history of renal transplantation
• Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period
• Pregnant, lactating, or planning during clinical trials
• Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period
• Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator
• Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures
• Those who have or are planning to administer other cell therapy products
• Those who are judged by the investigator to be inappropriate to participate in this clinical trial

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Hyosang

  Asan Medical Center Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 13, 2021
• Study Start: November 24, 2021
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)