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

An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 3B
• Intervention / Treatment: Biological: Cellgram-CKD

Detailed Description

The screening test is performed after the clinical trial subject consents in writing to participate in the clinical trial.

Subjects who meet the inclusion/exclusion criteria are registered in the clinical trial, and Cellgram-CKD is injected intravenously by puncturing a vein with a needle. After injecting Cellgram-CKD three times at an interval of 2 weeks (14 days), the subject visits the testing institution at 1 month, 3 months, 6 months, 9 months and 12 months for safety evaluation.

However, since the safety of Cellgram-CKD has not been established, proceed as follows.

In the first 3 subjects who received the investigational product, if no adverse events of Grade 3 or higher according to the NCI-CTCAE related to the investigational product occur 14 days after the 1st and 2nd administration, and 1 month after the 3rd administration, the remaining subjects were sequentially treated. Register as a member and conduct clinical trials.

If an adverse event of Grade 3 or higher according to the NCI-CTCAE standard related to the test drug occurs in two of the first three subjects, the clinical trial is terminated early. is conducted by registering three additional test subjects in the same way as the first.

If one or more of the three subjects develops a Grade 3 or higher adverse event related to the investigational product, the clinical trial is terminated early, and the remaining subjects are treated only if all three subjects do not have a Grade 3 or higher adverse reaction related to the investigational product. Register to continue the clinical trial.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cellgram-CKD; 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; Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in eGFR	Changes in eGFR after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline	1, 3, 6, 9, and 12 months of administration of the investigational product
Changes in BUN	Changes in BUN after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline	1, 3, 6, 9, and 12 months of administration of the investigational product
Changes in Creatinine	Changes in Creatinine after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline	1, 3, 6, 9, and 12 months of administration of the investigational product

Collaborators and Investigators

• Sponsor: Pharmicell Co., Ltd.
• Investigators: Principal Investigator: Kim Hyosang, Asan Medical Center Nephrology

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): September 21, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PMC-P-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No