NCT00767260

Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus

Autologous Bone Marrow Mononuclear Cell Infusion With Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There were evidences that the non-immune mediated inflammatory pathways of cell damage occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous stem cell therapies were an emerging set of therapies that showed promise with a low side effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained from bone marrow might provide multiple signals for regeneration and inflammation-induced lesion recovery of local tissues, of which the effect might be maximized by intra-arterial pancreatic infusion through angiography and combination with hyperbaric oxygen therapy. This trail includes a foregoing sub-trial that investigate the feasibility and safety of a novel method for massive bone marrow collection. The traditional BM collecting procedure is unfavorable because it yields minor bone marrow. Studies have shown that physiological exercise can increase bone marrow blood flow, which might facilitate BM collection. We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to either a control group or an exercise group (n =30 each). The patients in the exercise group exercised 30 minutes before the operation. All patients underwent routine surgical care. The collected BM volume, operation time, collecting speed , puncture times and pain scores during the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and whole blood cell count.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BM-MNC+HOT	Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy
DRUG	BM-MNC	Autologous Bone Marrow Mononuclear cell Infusion
DEVICE	HOT	Hyperbaric Oxygen Therapy
DRUG	SMT	hypoglycemic drugs or exogenous insulin

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-03-01
• Completion: 2015-03-01
• First posted: 2008-10-07
• Last updated: 2017-09-21

Locations

1 site across 1 country: China