Phase 1 Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells 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

The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations. The main question it aims to answer is: \- What medical problems do participants have after receiving Cellgram-CKD? Participants will: \- Receive Cellgram-CKD by intravenous infusion three times at 2-week intervals. Visit the clinic 1, 3, 6, 9, and 12 months after the third administration for safety assessments.

Conditions

Chronic Kidney Disease

Keywords

Cellgram-CKD; Chronic Kidney Disease; Mesenchymal Stem Cells; Chronic Kidney Disease Stage 3b; Chronic Kidney Disease Stage 4; Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

  From the first administration of the investigational product to 12 months after the third administration of the investigational product.

Secondary Outcomes (2)

• Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline

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

• Change in Blood Urea Nitrogen (BUN) and Creatinine From Baseline

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

Study Arms (1)

Cellgram-CKD

EXPERIMENTAL

Participants receive 5 × 10\^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) by intravenous infusion three times at 2-week (14-day) intervals.

Biological: Cellgram-CKD

Interventions

Cellgram-CKD BIOLOGICAL

5 × 10\^7 allogeneic bone marrow-derived mesenchymal stem cells (10 mL) administered by intravenous infusion three times at 2-week (14-day) intervals.

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 participants aged 19 to less than 80 years.
• Participants diagnosed with Stage 3b or Stage 4 chronic kidney disease (CKD) \[eGFR 15-44 mL/min/1.73 m²\] within 1 year prior to screening.
• Participants who voluntarily agree to participate in the clinical trial and provide written informed consent.

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: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)