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Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot

C

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown
Phase 1

Conditions

Diabetic Foot
Lower Limb Ischemia

Treatments

Biological: Mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02304588
CHIN-PLAGH-ST-001

Details and patient eligibility

About

Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.

Enrollment

20 estimated patients

Sex

All

Ages

30 to 78 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • the age of 30-78 years old, men and women there is no limit.
  • in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
  • with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
  • treatment on a voluntary basis, and sign the informed consent.

Exclusion criteria

  • with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
  • clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
  • the prodrome of acute infectious diseases.
  • participated in clinical subjects within three months before test.
  • adherence is poor, can not complete the course.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Mesenchymal stem cells
Experimental group
Description:
Maximal amount of MSC cells injected: 10-20\*10\^6 cells (up to volume of 20mL, depending on the wound size \& patient weight).
Treatment:
Biological: Mesenchymal stem cells

Trial contacts and locations

1

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Central trial contact

xiaobing FU

Data sourced from clinicaltrials.gov

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