Efficacy and safety of autologous marrow stem cell transplantation in patients with diabetic peripheral neuropathy: a double-blind, randomly paired trial. (November 2016)

• Record Type: Journal Article
• Authors: Shi, Xiaoxia; Zheng, Yueyue; Li, Ruige; Liu, Dexue
• Is Part Of: Lancet. Volume 4(2016)Supplement 1
• Page Start: S24
• Publication Date: 2016-11
• Subjects: Diabetes -- Periodicals; Endocrinology -- Periodicals; Endocrine glands -- Diseases -- Periodicals; 616.4
• DOI: 10.1016/S2213-8587(16)30379-5
• Languages: English
• ISSNs: 2213-8587

Abstract

Abstract: Background: A few reports with small sample sizes have shown that autologous marrow stem cell transplantation has had some effect on diabetic complications, however, no studies to our knowledge have been attempted for specifically diabetic peripheral neuropathy. We aimed to find the therapeutic effects of autologous marrow stem cell transplantation in patients with diabetic peripheral neuropathy in an observational study. Method: We did a double-blind, randomly paired trial with inclusion criteria of type 2 diabetes and with one of the following three conditions: the ends of the limbs showed paresthesia or disorder; the total score of Toronto symptom of more than 7·0 and one or more of single neuropathy conduct velocity slowed down up to less than 45 m/s in motor nerve or 40 m/s in sensory nerve; and an exclusion criteria of other diseases that lead to peripheral neuropathy and serious disease of the heart, liver, kidneys, or thyroid and parathyroid diseases. Patients enrolled in the study were divided into two groups according to the randomly paired design method according to three matching factors (ie, same sex, less than 5 years difference for age, and 2 years for course of the difference). For 3 years, both groups were given basic treatment, such as regular blood glucose adjustment and trophic nerve adjustment. Additionally, the observation group also underwent autologous marrow stem cell transplantation with a 100 ml of intravenous suspension with the number of cells of 10 million/kg according to bodyweight, while the control group were given 100 ml of intravenous saline at the beginning of treatment. Clinical symptom score and average limb nerve conduction velocity were assessed a day before the beginning of the therapy and followed up at 3 months, 6 months, 1 year, and 3 years after. The symptom effective rate was intended to be larger than two points of decrease of the total score of Toronto symptom. The primary clinical endpoints were symptom effective rate and average limb nerve conduction velocity at 3 years. The secondary endpoints were clinical symptom score and proportion of adverse events. The continuous variable data were analysed by single variance and with the t test, whereas the categorical variable data were tested by χ 2 . Informed patient consent was given by all participants. Findings: Between June 1, 2010, and May 1, 2014, 112 patients were divided into the control group (n=56) and the observation group (n=56). The symptom effective rate, average limb nerve conduction velocity, and clinical symptom score were associated with an improvement in the observation group compared with the control group. The symptom effective rate in the observation versus control group at 3 years was 84% (47 of 56) versus 43% (24 of 56; χ 2 =20·4, p<0·0001). Average limb nerve conduction velocity was 52·75 m/s in the observation group versus 41·32 m/s in the control group 3 years after treatment (t=16·86, p<0·0001). The clinical symptom scores in the observation group versus the control group was 4·05 versus 7·79 (t=12·96, p<0·0001) 3 years after treatment. Five patients had weakness and mild fever and recovered within 2–4 days in the observation group. There were no adverse events in control group. In both groups, no serious adverse events were reported. Interpretation: Patients given autologous marrow stem cell transplantation in addition to standard treatment for diabetic peripheral neuropathy were associated with an improved average limb nerve conduction velocity and clinical symptom scores compared with those on standard treatment alone. Funding: Education Commission of Henan Province, China: science and technology research key project (12B320012).