NCT00595257

Brief Summary

The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

December 19, 2007

Last Update Submit

March 8, 2012

Conditions

Arterial Occlusive Diseases

Keywords

PAD, CLI, Critical Limb Ischemia, bone marrow, stem cell, injection, infusion

Outcome Measures

Primary Outcomes (1)

  • avoid amputation

    60 days

Secondary Outcomes (1)

  • measurement of hemodynamic response

    60 Days

Study Arms (2)

1

EXPERIMENTAL

injection of BMAC into ischemic limb

Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)

2

ACTIVE COMPARATOR

Injection and Infusion of BMAC into ischemic lower limb

Device: centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)

Interventions

centrifuge, laboratory, tabletop (SmartPReP2 BMAC System)DEVICE

autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs

Also known as: SmartPReP2 BMAC System
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Critical Limb Ischemia per protocol (see diagnostic criteria #2) with regard to the study limb.
  • Existence of a PAOD with clinical presentation corresponding to Rutherford Category 4 or Category 5 as defined in the reporting standards adopted by the Society of Vascular Surgeons (table 1)
  • Patient meets at least one of the following diagnostic criteria in the study limb:
  • Ankle artery occlusion pressure absolute \<50 mmHg or ABI \<0.4
  • Toe artery occlusive pressure \< 40mm Hg or TBI (\<0.4)
  • TcPO2 \<20 mmHg lying down breathing room air, if available.
  • There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
  • Anatomical considerations
  • No outflow targets
  • No appropriate conduit (i.e. vein for bypass)
  • Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
  • High risk medical conditions
  • Unstable cardiac disease.
  • Renal insufficiency
  • History of prior failed revascularization attempts
  • +9 more criteria

You may not qualify if:

  • Life expectancy \<6 months due to concomitant illnesses
  • History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
  • Terminal renal failure with existing dependence on dialysis
  • Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free..
  • Poorly controlled diabetes mellitus (HgbA1C\>10%)
  • Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
  • Life-threatening complications of the ischemia necessitating immediate amputation
  • Uncorrected iliac artery occlusion on index side
  • Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
  • Active clinical infection being treated by antibiotics within one week of enrollment
  • Treatment with immunosuppressant drugs (including Prednisone \> 5 mg per day).
  • Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
  • Underwent a major cardiovascular surgical procedure (carotid endarterectomy, open arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or an adverse cardiovascular event (stroke or MI) within the 30 days prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sri Ramachandra University Medical Center

Porur, Chennai, 600 116, India

Location

MeSH Terms

Conditions

Arterial Occlusive DiseasesChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • R E Arasan, MD

    LifeCell India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

January 16, 2008

Study Start

December 1, 2007

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

IN(1)