Back to resultsClinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cellgram-CKD
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Stage 3B
Eligibility Criteria
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
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cellgram-CKD
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Changes in eGFR
Changes in eGFR after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Changes in BUN
Changes in BUN after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Changes in Creatinine
Changes in Creatinine after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05042206
Brief Title
Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmicell Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cellgram-CKD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Cellgram-CKD
Intervention Description
Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
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 Measure Information:
Title
Changes in eGFR
Description
Changes in eGFR after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Time Frame
1, 3, 6, 9, and 12 months of administration of the investigational product
Title
Changes in BUN
Description
Changes in BUN after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Time Frame
1, 3, 6, 9, and 12 months of administration of the investigational product
Title
Changes in Creatinine
Description
Changes in Creatinine after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline
Time Frame
1, 3, 6, 9, and 12 months of administration of the investigational product
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jho Hyunwoo
Phone
+82, 2-3496-0135
Email
hwjho92@pharmicell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Hyosang
Organizational Affiliation
Asan Medical Center Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyosang Kim, associate professor
Phone
+82, 2-3010-1439
Email
mateus@amc.seoul.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease
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