NCT01446055

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

September 23, 2011

Last Update Submit

October 8, 2011

Conditions

Critical Limb IschemiaPeripheral Arterial DiseaseBuerger's Disease

Keywords

Peripheral arterial diseaseBuerger's diseaseatherosclerotic arterial occlusionbone marrow mononuclear cellchronic limb ischemia

Outcome Measures

Primary Outcomes (1)

  • Cell treatment-related adverse event

    1. Temperature,Pulse,Respiration,Blood Pressure 2. Routine analysis of blood and urine, 3. Liver function(ALT：alanine aminotransferase,AST：aspartate transferase), Renal function(Blood urea nitrogen,Creatinine;) Function of coagulation(APTT,PT,Fib,TT） 4. ECG（Electrocardiography） 5. local inflammatory response 6. Cell-treatment related death 7. Cell-treatment related unexpected amputation.

    2-wk after bone marrow transplantation

Secondary Outcomes (10)

  • ulcer size

    Post bone marrow transplantation: 1, 3, 6, 12 months

  • rest pain score.

    Post bone marrow transplantation: 1，3, 6, 12 months

  • cold sensation score

    Post bone marrow transplantation:,1，3, 6, 12 months

  • claudication distance (m)

    Post bone marrow transplantation:1, 3, 6, 12 months

  • Resting ABI

    Post bone marrow transplantation: 1,3, 6, 12 months

  • +5 more secondary outcomes

Study Arms (2)

ResQ process group

EXPERIMENTAL

Autologous BM-MNC is enriched with ResQ process(an automatic cell separator). Then the cell product is transplanted into the ischemia limbs of a patient.

Device: ResQ processed bone marrow sample

Ficoll-based conventional method

ACTIVE COMPARATOR

A conventional method based on Ficoll cell separation is used to process bone marrow.

Device: Ficoll conventional cell processing method

Interventions

ResQ processed bone marrow sampleDEVICE

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

ResQ process group
Ficoll conventional cell processing methodDEVICE

Comparison of different cell processing methods

Ficoll-based conventional method

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fontaine's stage 2-4 or resting ABI \<0.7
  • age between 20 and 80 years old
  • sign informed consent, voluntary subjects
  • diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease

You may not qualify if:

  • poorly controlled diabetes (HBA1c\> 7.0%) and proliferative retinopathy (III-IV stage)
  • malignancy history in the past five years or serum level of tumor markers elevated more than doubled
  • severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate BM-MNC transplantation
  • serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major amputation cannot be avoided
  • aortic or iliac or common femoral artery occlusion
  • pregnant female, or reproductive age female who wants to give birth throughout the course of the study
  • life expectancy less than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuan Wu Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaPeripheral Arterial DiseaseThromboangiitis Obliterans

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaVasculitis

Study Officials

  • Yong-Quan Gu, Dr.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongquan Gu, MD

CONTACT

13910002909gu-yq@263.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Vascular Surgery Department, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

September 23, 2011

First Posted

October 4, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

CN(1)