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Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia

NCT01446055 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-10-12

No results posted yet for this study

Summary

Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb ischemia has been proved safe and effective. However, processing bone marrow by Ficoll density gradient centrifugation is not only time consuming but also expensive. Manually processing of bone marrow also results in large variation in therapeutic cell quantity and quality which directly leads deviation of safety and efficacy of the cell therapy. This study is aiming to compare an automated bone marrow processing system with a conventional manual method in term of safety and efficacy.

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Buerger's Disease

Interventions

DEVICE

ResQ processed bone marrow sample

Autologous bone marrow is processed with ResQ at point of care, prior to the transplantation

DEVICE

Ficoll conventional cell processing method

Comparison of different cell processing methods

Sponsors & Collaborators

  • Thermogenesis Corp.

    collaborator INDUSTRY

  • Hebei Medical University

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Yong-Quan Gu, Dr. · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-04-30
Completion
2013-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446055 on ClinicalTrials.gov