Question

Is stem cell therapy for Chronic Kidney Disease FDA-approved?

No stem-cell product for CKD has FDA approval as a primary therapeutic agent. Ongoing investigational protocols operate under IND and expanded-access pathways. REGEN-CKD (regenerative-medicine network) and similar consortia are enrolling patients globally. European regulatory frameworks permit compassionate-use access in some jurisdictions for advanced-stage patients with limited conventional alternatives.

How stem cells are studied for Chronic Kidney Disease

Chronic kidney disease (CKD) reflects progressive nephron loss and functional decline, stemming from diverse primary insults (diabetes, hypertension, glomerulonephritis, polycystic kidney disease). Placental mesenchymal stem cells and their exosomes demonstrate anti-inflammatory and pro-regenerative properties relevant to CKD pathophysiology: they suppress macrophage infiltration into damaged glomeruli, inhibit fibrotic signalling pathways (TGF-β, SMAD2/3), and release growth factors that stabilise endothelial integrity. Eighty-eight registered trials and nine actively recruiting sites explore MSC infusion alongside conventional renin-angiotensin blockade and immunosuppression, particularly in early-to-intermediate stage disease where residual filtration capacity remains.

Am I a candidate? → · Chronic Kidney Disease: full overview → · Chronic Kidney Disease cost → · Cost →

Medically reviewed by StemCellAtlas’s editorial team with Dr Polina Krasenova (Haematologist · Clinical Haematology & Integrative Oncology · 15+ yrs cell therapy) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.

欧洲品质的细胞疗法,没有欧洲的价格。

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