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Peripheral Blood Autologous CD34+ Cell Transplantation Promotes Angiogenesis With Atherosclerotic Ischemia for Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098771
Recruitment Status : Unknown
Verified March 2017 by Lili Xu, Qingdao University.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Lili Xu, Qingdao University

Brief Summary:
To verify angiogenesis in elderly patients with atherosclerotic ischemia after peripheral blood autologous CD34+ cell transplantation.

Condition or disease Intervention/treatment Phase
Atherosclerotic Ischemic Disease Procedure: the cell transplantation group Drug: the control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Inpatients of the Qingdao No. 9 People's Hospital will be recruited. Potential participants can contact the project manager via telephone. After providing informed consent, these potential participants will be screened using the inclusion and exclusion criteria.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: the cell transplantation group
Patients with atherosclerotic lower limb ischemia will be randomly assigned to the cell transplantation group, which peripheral blood CD34+ cells transfected with ActiveMax® recombinant human vascular endothelial growth factor 165 (VEGF165) gene will be transplanted into the muscles of ischemic limbs in elderly patients with atherosclerotic lower limb ischemia.
Procedure: the cell transplantation group
Patients with atherosclerotic lower limb ischemia will be randomly assigned to the cell transplantation group, which peripheral blood CD34+ cells transfected with ActiveMax® recombinant human vascular endothelial growth factor 165 (VEGF165) gene will be transplanted into the muscles of ischemic limbs in elderly patients with atherosclerotic lower limb ischemia.

Experimental: the control group
Patients with atherosclerotic lower limb ischemia will be randomly assigned to the control group, which 9% physiological saline will be injected into the muscles of ischemic limbs.
Drug: the control group
Patients with atherosclerotic lower limb ischemia will be randomly assigned to the control group, which 9% physiological saline will be injected into the muscles of ischemic limbs.
Other Name: the physiological saline group




Primary Outcome Measures :
  1. ankle-brachial index (ABI) [ Time Frame: Change from baseline ankle-brachial index (ABI) at 6 months ]
    To assess lower limb ischemia. Ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium; Appendix 1). The range of ABI of normal persons at resting is between 0.9 and 1.3. Abnormal results: less than 0.8 represents moderate disease; less than 0.5 represents severe disease. The ABI of intermittent claudication patients is mainly between 0.35 and 0.9. The ABI of rest pain patients is often less than 0.4, and the patient will be at risk of amputation. ABI of more than 1.3 indicates vascular wall calcification and loss of vascular contraction.


Secondary Outcome Measures :
  1. Number of microvessels in the lower limb muscles [ Time Frame: Change from baseline ankle-brachial index (ABI) at 6 months ]
    To observe the changes in microvessel number.Five fields will be randomly selected under a high power microscope (× 400). High number of microvessels indicates the generation of more new blood vessels.



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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly patients with arteriosclerosis obliterans (Rutherford classification of class 5: slight tissue defect; class 6: tissue ulceration, gangrene)
  • Diabetic foot, Wagnar classification of class 315: deep ulcer, often affecting bone tissue, with deep abscess or osteomyelitis
  • Age range: 50-60 years
  • Irrespective of gender
  • Unilateral limb lesions
  • Total occlusion of main blood vessels
  • No outflow tract in distal arteries
  • Cannot perform open surgery and endovascular surgery
  • Signed informed consent

Exclusion Criteria:

  • Moderate to severe liver and kidney dysfunction
  • Malignant tumor
  • Hematological system diseases
  • Rheumatic immune system diseases
  • Poor stimulating effect on colony stimulating factor
  • Thromboangiitis obliterans
  • Severe hyperthyroidism
  • Endocrine and metabolic diseases such as severe hypothyroidism

Information from the National Library of Medicine

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): NCT03098771


Contacts
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Contact: Lili Xu, Ph.D 8618661802028 xulili201314@126.com

Sponsors and Collaborators
Qingdao University
Investigators
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Principal Investigator: Lili Xu, Ph.D The Affiliated Hospital of Qingdao University
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Responsible Party: Lili Xu, Principal Investigator, Qingdao University
ClinicalTrials.gov Identifier: NCT03098771    
Other Study ID Numbers: QingdaoU_001
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes