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The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Arm 1 | Experimental | Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in two intravenous infusions of 100x10^6 cells at time zero and three months |
|
| Dose Arm 2 | Experimental | Subjects with chronic kidney disease will receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) single intravenous infusion of 200x10^6 cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose-derived mesenchymal stem cells (MSC) | Drug | Two intravenous infusions delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 100x10^6 cells at day 0 and day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and/or serious adverse events | Number of adverse events and/or serious adverse events associated with mesenchymal stem cells intervention | 15 months |
| Change in eGFR Value | Blood serum estimated glomerular filtration rate (eGFR) reported in milliliters per minute (mL/min) | 6 months |
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Inclusion Criteria:
Age 30-80 years
Estimated glomerular filtration rate (eGFR) 25-55 ml/min/1.73m2
Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy
Ability to give informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LaTonya Hickson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40333016 | Derived | Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available. | |
| 40009460 | Derived |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Allogeneic adipose-derived mesenchymal stem cells (MSC) | Drug | Single intravenous infusion delivered systemically through a peripheral IV(over 30 minutes to 2 hours) of 200x10^6 cells at day 0 |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |