Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03098771
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2017-03-22
Brief Title:
Peripheral Blood Autologous CD34 Cell Transplantation Promotes Angiogenesis With Atherosclerotic Ischemia for Elderly
Sponsor:
Qingdao University
Organization:
Qingdao University
Study Overview
Official Title:
Peripheral Blood Autologous CD34 Cell Transplantation Promotes Angiogenesis in Elderly Patients With Atherosclerotic Ischemia Study Protocol for a Prospective Single-center Open-label Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
NOT_YET_RECRUITING
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:
To verify angiogenesis in elderly patients with atherosclerotic ischemia after peripheral blood autologous CD34 cell transplantation
Detailed Description:
History and current related studies Arteriosclerosis obliterans is a kind of arterial lumen stenosis and occlusive disease which is caused by the continuous expansion of arterial atherosclerosis and secondary thrombosis Clinical manifestations are local skin temperature reduction intermittent claudication rest pain ulcers difficult to heal and gangrene infectionSome patients require amputation or even it is life-threatening Arteriosclerosis obliterans of lower limbs are commonly treated by surgical treatment endovascular treatment and non-surgical treatment but the effect is not very satisfactory
For the treatment of arteriosclerosis obliterans stem cell transplantation has achieved great progress in angiogenesis and collateral circulation There are two main mechanisms of stem cells involved in angiogenesis 1 Promoting differentiation and maturation of new blood vessels by homing and integration in the damaged vascular plexus 2 Promoting angiogenesis in ischemic tissue by paracrine of vascular endothelial growth factor VEGFIn recent years because of the discovery of endothelial progenitor cells in peripheral blood the concept of angiogenesis has been renewed Transplantation of endothelial progenitor cells and bone marrow cells for angiogenesis has become the focus of research Endothelial progenitor cell and bone marrow cell transplantation have been used to promote angiogenesis in ischemic tissue in order to treat limb ischemia
Bone marrow stem cell mobilization is used to promote the replication of bone marrow stem cells so as to increase the number of endothelial progenitor cells in peripheral blood ie the number of stem cells homing to ischemic tissue and finally accelerating the speed and magnitude of angiogenesis Fujisaki et al have confirmed that bone marrow cell mobilizers can significantly stimulate bone marrow hematopoiesis and increase the number of peripheral blood stem cellsBone marrow cell mobilizer-recombinant human granulocyte colony stimulating factor rhG-CSF are used to mobilize bone marrow stem cells to peripheral blood and to increase the number of peripheral blood stem cells especially endothelial progenitor cells so as to treat ischemic diseases using transplanted autologous stem cells which is called autologous stem cell transplantation Nevertheless in animal and human experiments the proliferation potential and influencing factors of mobilized bone marrow stem cells and peripheral blood endothelial progenitor cells in ischemic tissue require further investigations
Autologous stem cell transplantation is to transplant stem cells in muscles of ischemic limb so that new capillaries improve and restore lower limb blood flow aiming to treat lower limb ischemia Endothelial progenitor cells and hematopoietic stem cells are thought to come from a common ancestor and called blood vessel stem cells They express immature stem cell markers CD34 and CD133 Endothelial progenitor cells migrated from bone marrow to peripheral blood will gradually lose CD133 and the disappearance of CD34 is relatively slow A large number of basic and clinical studies have confirmed that the transplantation of CD34 cells can promote angiogenesis in ischemic limbs of experimental animals partial patients
Adverse events
1 To record adverse events including fever infection lower limb pain and ulcers during follow-up at out-patient clinic
2 If severe adverse events occur investigators will report details including the date of occurrence and measures taken to treat the adverse events to the principle investigator and the institutional review board within 24 hours
Data collection management analysis open access
1 Data collection Case report forms will be collected and processed using Epidata software Epidata Association Odense Denmark collated and then recorded electronically using a double-data entry strategy
2 Data management The locked electronic database will be accessible and locked only by the project manager This arrangement will not be altered The Qingdao No 9 Peoples Hospital China will preserve all of the data regarding this trial
3 Data analysis A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers An independent data monitoring committee will supervise and manage the trial data ensuring a scientific and stringent trial that yields accurate and complete data
4 Data open access Anonymized trial data will be published at wwwfigsharecom
Statistical analysis
1 Statistical analysis will be performed using SPSS 190 software IBM Armonk NY USA and will follow the intention-to-treat principle
2 Normally distributed measurement data will be expressed as means standard deviation minimums and maximums Non-normally distributed measurement data will be expressed as the lower quartile q1 median and upper quartiles q3 Count data will be expressed as a percentage
3 Kolmogorov-Smirnov test will be used to determine normality of measurement data If data obey the normal distribution ABI number of microvessels in the lower limb muscles and number of VEGF-immunoreactive cells will be compared with two-sample t-test between the two groups Intragroup difference of above indicators will be compared using paired t-test before and 6 months after transplantation If data do not obey the normal distribution intergroup and intragroup data will be compared using Mann Whitney U test and Wilcoxon signed-rank test The incidence of adverse reactions will be compared with Fishers exact probability test between the two groups 6 months after transplantation
4 The significance level will be α 005
For the treatment of arteriosclerosis obliterans stem cell transplantation has achieved great progress in angiogenesis and collateral circulation There are two main mechanisms of stem cells involved in angiogenesis 1 Promoting differentiation and maturation of new blood vessels by homing and integration in the damaged vascular plexus 2 Promoting angiogenesis in ischemic tissue by paracrine of vascular endothelial growth factor VEGFIn recent years because of the discovery of endothelial progenitor cells in peripheral blood the concept of angiogenesis has been renewed Transplantation of endothelial progenitor cells and bone marrow cells for angiogenesis has become the focus of research Endothelial progenitor cell and bone marrow cell transplantation have been used to promote angiogenesis in ischemic tissue in order to treat limb ischemia
Bone marrow stem cell mobilization is used to promote the replication of bone marrow stem cells so as to increase the number of endothelial progenitor cells in peripheral blood ie the number of stem cells homing to ischemic tissue and finally accelerating the speed and magnitude of angiogenesis Fujisaki et al have confirmed that bone marrow cell mobilizers can significantly stimulate bone marrow hematopoiesis and increase the number of peripheral blood stem cellsBone marrow cell mobilizer-recombinant human granulocyte colony stimulating factor rhG-CSF are used to mobilize bone marrow stem cells to peripheral blood and to increase the number of peripheral blood stem cells especially endothelial progenitor cells so as to treat ischemic diseases using transplanted autologous stem cells which is called autologous stem cell transplantation Nevertheless in animal and human experiments the proliferation potential and influencing factors of mobilized bone marrow stem cells and peripheral blood endothelial progenitor cells in ischemic tissue require further investigations
Autologous stem cell transplantation is to transplant stem cells in muscles of ischemic limb so that new capillaries improve and restore lower limb blood flow aiming to treat lower limb ischemia Endothelial progenitor cells and hematopoietic stem cells are thought to come from a common ancestor and called blood vessel stem cells They express immature stem cell markers CD34 and CD133 Endothelial progenitor cells migrated from bone marrow to peripheral blood will gradually lose CD133 and the disappearance of CD34 is relatively slow A large number of basic and clinical studies have confirmed that the transplantation of CD34 cells can promote angiogenesis in ischemic limbs of experimental animals partial patients
Adverse events
1 To record adverse events including fever infection lower limb pain and ulcers during follow-up at out-patient clinic
2 If severe adverse events occur investigators will report details including the date of occurrence and measures taken to treat the adverse events to the principle investigator and the institutional review board within 24 hours
Data collection management analysis open access
1 Data collection Case report forms will be collected and processed using Epidata software Epidata Association Odense Denmark collated and then recorded electronically using a double-data entry strategy
2 Data management The locked electronic database will be accessible and locked only by the project manager This arrangement will not be altered The Qingdao No 9 Peoples Hospital China will preserve all of the data regarding this trial
3 Data analysis A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers An independent data monitoring committee will supervise and manage the trial data ensuring a scientific and stringent trial that yields accurate and complete data
4 Data open access Anonymized trial data will be published at wwwfigsharecom
Statistical analysis
1 Statistical analysis will be performed using SPSS 190 software IBM Armonk NY USA and will follow the intention-to-treat principle
2 Normally distributed measurement data will be expressed as means standard deviation minimums and maximums Non-normally distributed measurement data will be expressed as the lower quartile q1 median and upper quartiles q3 Count data will be expressed as a percentage
3 Kolmogorov-Smirnov test will be used to determine normality of measurement data If data obey the normal distribution ABI number of microvessels in the lower limb muscles and number of VEGF-immunoreactive cells will be compared with two-sample t-test between the two groups Intragroup difference of above indicators will be compared using paired t-test before and 6 months after transplantation If data do not obey the normal distribution intergroup and intragroup data will be compared using Mann Whitney U test and Wilcoxon signed-rank test The incidence of adverse reactions will be compared with Fishers exact probability test between the two groups 6 months after transplantation
4 The significance level will be α 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None