Recruitment

Recruitment Status
Completed

Inclusion Criterias

Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits.
Ankle Brachial Pressure Index (ABI) ≤ 0.6 or the absolute ankle blood pressure < 60 mm Hg or TcPO2<20 mmHg without tissue loss or TcPO2<40 mmHg if there is tissue loss or alternatively toe Brachial Pressure Index (TBI) less 0.5 or the absolute toe blood pressure less than 50 mm Hg
Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
...
Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits.
Ankle Brachial Pressure Index (ABI) ≤ 0.6 or the absolute ankle blood pressure < 60 mm Hg or TcPO2<20 mmHg without tissue loss or TcPO2<40 mmHg if there is tissue loss or alternatively toe Brachial Pressure Index (TBI) less 0.5 or the absolute toe blood pressure less than 50 mm Hg
Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
No immediate life-threatening complication from CLI which would demand immediate amputation.
On optimal medical therapy
No surgical or interventional option for revascularization and no response to best standard care delivered as confirmed by a vascular surgeon and/or physician.
Male and Female patients in the age group of 18-80yrs.
If diabetic, HgbA1c <10%

Exclusion Criterias

Known bone marrow diseases which preclude transplantation.
Patients with a history of severe alcohol or drug abuse within 3 months of screening.
Laboratory values as show below*
...
Known bone marrow diseases which preclude transplantation.
Patients with a history of severe alcohol or drug abuse within 3 months of screening.
Laboratory values as show below*
Myocardial infarction / CVA / TIA within the past three months prior to enrollment
If diabetic, diagnosis of proliferative retinopathy
Revascularization procedure in target limb within 6 weeks prior to enrollment
End-stage renal failure on regular dialysis treatment. Creatinine ≥2.0 mg/dl
Patients tested positive for HIV screen1or2, Hepatitis C antibody Hepatitis B surface-antigen, HepatitisBcore Antibody, Syphilis screen
Patients with infected ulcers or systemic infections *Laboratory Values: Hemoglobin <10 g/dL Platelet count <100,000/microL ALT >60 U/L AST >60 U/L Bilirubin >1.0 mg/dL INR >1.3 unless on Coumadin and at Investigator discretion APTT >40 second unless on Lovenox or Heparin and at Investigator's discretion
Acute life threatening complication of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
Patients with confirmed Rutherford 6 condition with extensive tissue damage
Patients already enrolled in another investigational drug trial or completed within 1month.
Patients with documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 6 months.
Currently taking immunosuppressive agents
Pregnancy.

Summary

Conditions
Critical Limb Ischemia
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Autologous treatment for CLI open labelMasking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Efficacy will be determined by number of collateral arteries as assessed magnetic resonance angiography at baseline and again at 3 months, rate of major amputation (above the ankle) of the affected limb within 3 months or an unchanged critical limb ischemia of the affected limb after 3 months define...

Efficacy will be determined by number of collateral arteries as assessed magnetic resonance angiography at baseline and again at 3 months, rate of major amputation (above the ankle) of the affected limb within 3 months or an unchanged critical limb ischemia of the affected limb after 3 months defined as less than 15% change in tcPO2 or ABI or absolute ankle pressure.Efficacy endpoint is at 3 months. Clinical endpoints and safety will be measured through 12 months.

Inclusion Criterias

Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits.
Ankle Brachial Pressure Index (ABI) ≤ 0.6 or the absolute ankle blood pressure < 60 mm Hg or TcPO2<20 mmHg without tissue loss or TcPO2<40 mmHg if there is tissue loss or alternatively toe Brachial Pressure Index (TBI) less 0.5 or the absolute toe blood pressure less than 50 mm Hg
Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
...
Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits.
Ankle Brachial Pressure Index (ABI) ≤ 0.6 or the absolute ankle blood pressure < 60 mm Hg or TcPO2<20 mmHg without tissue loss or TcPO2<40 mmHg if there is tissue loss or alternatively toe Brachial Pressure Index (TBI) less 0.5 or the absolute toe blood pressure less than 50 mm Hg
Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
No immediate life-threatening complication from CLI which would demand immediate amputation.
On optimal medical therapy
No surgical or interventional option for revascularization and no response to best standard care delivered as confirmed by a vascular surgeon and/or physician.
Male and Female patients in the age group of 18-80yrs.
If diabetic, HgbA1c <10%

Exclusion Criterias

Known bone marrow diseases which preclude transplantation.
Patients with a history of severe alcohol or drug abuse within 3 months of screening.
Laboratory values as show below*
...
Known bone marrow diseases which preclude transplantation.
Patients with a history of severe alcohol or drug abuse within 3 months of screening.
Laboratory values as show below*
Myocardial infarction / CVA / TIA within the past three months prior to enrollment
If diabetic, diagnosis of proliferative retinopathy
Revascularization procedure in target limb within 6 weeks prior to enrollment
End-stage renal failure on regular dialysis treatment. Creatinine ≥2.0 mg/dl
Patients tested positive for HIV screen1or2, Hepatitis C antibody Hepatitis B surface-antigen, HepatitisBcore Antibody, Syphilis screen
Patients with infected ulcers or systemic infections *Laboratory Values: Hemoglobin <10 g/dL Platelet count <100,000/microL ALT >60 U/L AST >60 U/L Bilirubin >1.0 mg/dL INR >1.3 unless on Coumadin and at Investigator discretion APTT >40 second unless on Lovenox or Heparin and at Investigator's discretion
Acute life threatening complication of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
Patients with confirmed Rutherford 6 condition with extensive tissue damage
Patients already enrolled in another investigational drug trial or completed within 1month.
Patients with documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 6 months.
Currently taking immunosuppressive agents
Pregnancy.

Locations

North Kansas City, Missouri, 64116
North Kansas City, Missouri, 64116

Tracking Information

NCT #
NCT01867190
Collaborators
Not Provided
Investigators
Study Director: Paul T Sudhakar, MS, Pharm Lifecells, LLC.