NCT03098771

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

March 22, 2017

Last Update Submit

March 27, 2017

Conditions

Atherosclerotic Ischemic Disease

Outcome Measures

Primary Outcomes (1)

  • ankle-brachial index (ABI)

    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.

    Change from baseline ankle-brachial index (ABI) at 6 months

Secondary Outcomes (1)

  • Number of microvessels in the lower limb muscles

    Change from baseline ankle-brachial index (ABI) at 6 months

Study Arms (2)

the cell transplantation group

EXPERIMENTAL

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

the control group

EXPERIMENTAL

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

Interventions

the cell transplantation groupPROCEDURE

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.

the cell transplantation group
the control groupDRUG

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.

Also known as: the physiological saline group
the control group

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lili Xu, Ph.D

    The Affiliated Hospital of Qingdao University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Xu, Ph.D

CONTACT

8618661802028xulili201314@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 4, 2017

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2020

Last Updated

April 4, 2017

Record last verified: 2017-03