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CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLBS201 | Experimental | CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLBS201 | Drug | 1 x 10^6 to 300 x 10^6 autologous CD34+ cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Proportion of patients with a treatment-emergent serious adverse event | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) | Change in eGFR from baseline | 6 Months |
| UACR & UPCR | Change in UACR & UPCR from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen K Buck, MD | Lisata Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 6 Months |
| 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 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D048909 | Diabetes Complications |