Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00767260
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2008-10-06
Brief Title:
Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus
Sponsor:
Fuzhou General Hospital
Organization:
Fuzhou General Hospital
Study Overview
Official Title:
Autologous Bone Marrow Mononuclear Cell Infusion With Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None