Adults with severe forms of diabetic kidney disease along with limb ischemia can benefit from delays in the need for amputation with autologous cell therapy compared with traditional treatments, according to findings published in Diabetic Medicine.
“People with critical limb ischemia and diabetic kidney disease (DKD) have a less favorable response to improvement in ischemia when treated conservatively (medically), therefore, newer therapeutic techniques, such as cell therapy for these ‘no-option’ people (those not eligible for standard revascularization) have been studied in clinical trials,” Michal Dubský, MD, PhD, physician and researcher at the Institute for Clinical and Experimental Medicine in Prague, and colleagues wrote. “But most studies usually exclude people with end-stage renal disease or even DKD.”
Between 2008 and 2016, Dubský and colleagues recruited 59 adults treated with autologous cell therapy at the Institute for Clinical and Experimental Medicine for critical limb ischemia. Among these participants, 17 had severe DKD (mean age, 61 years; 18% women) and 42 had DKD that was not classified as severe (mean age, 62 years; 19% women). A control group that received standard medical treatment was also recruited and consisted of 21 adults with severe DKD (mean age, 63 years; 24% women) and 23 without a severe form of the condition (mean age, 59 years; 22% women).
During the 18-month study, the two groups were evaluated for overall survival and amputation-free survival, the researchers wrote.
Cell therapy did not influence overall survival, but the researchers noted that compared with traditional treatment, those who received cell therapy achieved longer amputation-free survival time (P = .009). Paired comparisons further revealed those with severe DKD who received cell therapy had superior amputation-free survival than those with severe DKD treated with traditional methods (HR = 0.36; 95% CI, 0.14-0.91). According to the researchers, those with nonsevere DKD who had cell therapy had a higher percentage of ulcers healed at 12 months compared with those receiving traditional therapy (82.1% vs. 30%; P < .001) and at 18 months compared with the corresponding control group (69.2% vs. 25%; P = .003). The researchers noted a similar finding for those with severe DKD and cell therapy compared with the corresponding control group (50% vs. 18.8%; P = .006) at 18 months.
“Even in the presence of severe DKD, those with no-option severe limb ischemia cell therapy could have a therapeutic benefit,” the researchers wrote. “The challenge that arises from the present study is to know when to use autologous cell therapy; it is a promising treatment in people with critical limb ischemia and can improve ischemia also in people with severe kidney disease, but it is necessary to carefully treat the associated complications that could affect mortality and major amputation risk.” – by Phil Neuffer
Disclosures: The authors report no relevant financial disclosures.