title: Autologous bone marrow mononuclear cell infusion and hyperbaric oxygen therapy in type 2 diabetes mellitus: an open-label, randomized controlled clinical trial.
abstract: OBJECTIVE
  The use of bone marrow mononuclear cells (BM-MNCs) has achieved great outcomes in clinical practice. We aim to evaluate the efficacy and safety of autologous BM-MNC infusion and hyperbaric oxygen therapy (HOT) in type 2 diabetes mellitus.
  
  
  METHODS
  This single-center, randomized, open-label, controlled clinical trial with a factorial design included two phases. The patients received standard medical therapy in the run-in phase; in the treatment phase, patients with glycated hemoglobin of 7.5-9.5% were randomly assigned into four groups and underwent BM-MNC infusion along with HOT (BM-MNC+HOT group), BM-MNC infusion (BM-MNC group), HOT (HOT group) and standard medical therapy (control group), respectively. The area under the curve of C-peptide was recorded as a primary end point. Our research is registered at ClinicalTrials.gov (NCT00767260).
  
  
  RESULTS
  A total of 80 patients completed the follow-up. At 12 months after treatment, the area under the curve of C-peptide (ng/mL per 180 min) of the BM-MNC+HOT group and the BM-MNC group were significantly improved (34.0% and 43.8% from the baseline, respectively). The changes were both significant compared with that in the control group, but no remarkable change was observed in the HOT group. Treatment-related adverse events were mild, including transient abdominal pain (n = 5) and punctual hemorrhage (n = 3).
  
  
  CONCLUSIONS
  BM-MNC infusion for type 2 diabetes mellitus improves islet function and metabolic control, with mild adverse effects. HOT does not synergize with BM-MNC infusion.
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Zhixian
authors.initials: Z
authors.lastname: Wu
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Jinquan
authors.initials: J
authors.lastname: Cai
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Jin
authors.initials: J
authors.lastname: Chen
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Lianghu
authors.initials: L
authors.lastname: Huang
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Weizhen
authors.initials: W
authors.lastname: Wu
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Fang
authors.initials: F
authors.lastname: Luo
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Chenguang
authors.initials: C
authors.lastname: Wu
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China.
authors.forename: Lianming
authors.initials: L
authors.lastname: Liao
authors.affiliation: Organ Transplant Institute, Fuzhou General Hospital, Xiamen University, Fuzhou, Peoples Republic of China. Electronic address: doctortjm@yahoo.com.
authors.forename: Jianming
authors.initials: J
authors.lastname: Tan
mesh_terms: D000368:Aged; D001854:Bone Marrow Cells / Q000378:metabolism* / Q000473:pathology; D017690:Cell Transplantation; D002478:Cells, Cultured; D003131:Combined Modality Therapy; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006931:Hyperbaric Oxygenation; D050417:Insulin-Secreting Cells / Q000378:metabolism* / Q000473:pathology; D007963:Leukocytes, Mononuclear / Q000378:metabolism / Q000473:pathology / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
keywords: bone marrow; hyperbaric oxygen therapy; mononuclear cells; type 2 diabetes mellitus