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Completed

NCT Number: NCT02287831

Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic foot, and to evaluate the safety and efficacy of the implantation procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18-75 years
  • Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9
  • Poor distal arterial outflow tract
  • Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
  • Poor physical condition can not tolerate surgery
  • Patients are willing to participate in the study and sign the informed consent.

Exclusion criteria

  • Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
  • Severe or acute organ damage
  • Presence of malignancy
  • Pregnancy or lactating patients
  • HIV positive
  • ABI≧0.9
  • A history of severe allergies related cell therapy
  • Conservative treatment < 3 months
  • Acute limb ischemia
  • Local obvious infection uncontrolled
  • Alcoholics or drug abusers within a year
  • Severe psychiatric disorder.
  • Patients need surgical treatment
  • Above the ankle gangrene
  • Patients with other factors which were considered not to be suitable to participate in the study by the investigators.

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

Primary outcomes

  1. To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.

    Time frame: 6 months

    Amputation rate and mortality will be combined to report safty in %

Secondary outcomes

  1. To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.

    Time frame: 6 months

    Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Nov 11, 2014
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.