Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia
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|ClinicalTrials.gov Identifier: NCT01937416|
Recruitment Status : Unknown
Verified December 2013 by Quanhai Li, Hebei Medical University.
Recruitment status was: Recruiting
First Posted : September 9, 2013
Last Update Posted : December 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Lower Limb Ischemia||Biological: autologous bone marrow mononuclear cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||December 2014|
Experimental: autologous bone marrow mononuclear cells
Bone marrow come from the patients himself/herself. With a conventional method and reagent,Ficoll, mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation.
Biological: autologous bone marrow mononuclear cells
Bone marrow was taken from patient oneself and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection.
- Cell transplantation related side effect [ Time Frame: 2 week after cell transplantation ]Temperature,pulse,respiration,blood pressure,routine analysis of blood and urine, liver function,renal function,function of coagulation, ECG,cell transplantation related death and cell transplantation related unexpected amputation
- ulcer size [ Time Frame: Post cell transplantation: 1, 3, 6 months ]Measuring ulcer area (cm2) and depth (mm)of limb : For each ulcer , photographically record the area and depth with a ruler in order to calculate the ulcer area in square millimeters.
- rest pain score [ Time Frame: Post cell transplantation: 1,3, 6 months ]
Scoring the rest pain based on the degree of pain as following five scales): 0 level-0 point: no pain;
- level-1 point: occasional pain which can be recalled;
- level-2 points: the pain often but can be tolerated, without or with a little analgesics;
- level-3 points: often with need of general analgesics;
- level -4 points: affect sleeping due to the pain, general pain medication being difficult to alleviate.
Before transplantation: points; after transplantation: points.
- cold sensation score [ Time Frame: Post cell transplantation: 1,3, 6 months ]
based on a sense of cold as following five scales: 0 level-0 point: no cold sensation;
- level-1 point, or : Occasionally cold feeling;
- level-2 points: Often with cold feeling;
- level-3 points: significantly cold feeling. and can be significantly improved when using a local insulation.
- level-4 points: significantly cold feeling,and can not be significantly improved when using a local insulation.
- Resting ABI [ Time Frame: Post cell transplantation: 1,3, 6 months ]Measurement of ABI(ankle brachial index, ABI): Measure arterial pressure with a laser Doppler, and then calculate the ankle-brachial index, that is a ratio of ankle arterial blood pressure to brachial arterial blood pressure at rest.
- Resting TcPO2 (mmHg) [ Time Frame: Post cell transplantation:1, 3, 6 months ]Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest.
- Collateral vessel score [ Time Frame: Post cell transplantation: 1,3, 6 months ]
Collateral vessel score: Using computed tomographic angiography to score the collateral vessel formation. A mean score is obtained for each ischemic limb by 3 independent interventionists based on the following 4 level score: 0 (no new collateral vessels)
- (A little new collateral vessels)
- (moderate new collateral blood vessels)
- (Rich new collateral vessels)
- Skin microcirculation measurement [ Time Frame: 1,3,6 months post cell transplantation ]using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937416
|the First Hospital of Hebei Medical University||Recruiting|
|Shijiazhuang, Hebei, China, 050000|
|Contact: Xu Han, master 86-311-85917202 firstname.lastname@example.org|
|Study Chair:||Baoyong Yan, Doctor||The First Hospital of Hebei Medical University|
|Study Director:||Huimin Zhou, doctor||The First Hospital of Hebei Medical University|
|Principal Investigator:||Xu Han, master||The First Hospital of Hebei Medical University|
|Principal Investigator:||Quanhai Li, doctor||The First Hospital of Hebei Medical University|