| Trial ID: | L1898 |
| Source ID: | NCT00767260
|
| Associated Drug: |
Bm-Mnc+Hot
|
| Title: |
Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: BM-MNC+HOT|DRUG: BM-MNC|DEVICE: HOT|DRUG: SMT
|
| Outcome Measures: |
Primary: area under the curve of c-peptide, 1 year | Secondary: The incidence and severity of adverse events related to the stem cell infusion procedure, 1 year|The incidence and severity of adverse events related to the hyperbaric oxygen therapy, 1 year|HbA1c, 1 year|exogenous insulin requirements, 1 year|fasting hemoglucose, 1 year|fasting c-peptide, 1 year|area under the curve of serum insulin, 1 year
|
| Sponsor/Collaborators: |
Sponsor: Fuzhou General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
82
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2015-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-09-21
|
| Locations: |
Fuzhou General Hospital, Fuzhou, Fujian, 350025, China
|
| URL: |
https://clinicaltrials.gov/show/NCT00767260
|