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Trial record 1 of 1 for:    IND 15069
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Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia (CLI)

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ClinicalTrials.gov Identifier: NCT01867190
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Lifecells, LLC.

Tracking Information
First Submitted Date  ICMJE May 29, 2013
First Posted Date  ICMJE June 3, 2013
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE May 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
To assess the efficacy and safety of intra-arterial infusion and intramuscular injection of ASCT01 on the combined primary endpoint of major amputation (above the ankle) or persisting critical limb ischemia (no clinical or perfusion improvement). [ Time Frame: primary outcome measured at 3 months ]
The primary outcome variable is "treatment failure" defined as 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01867190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia
Official Title  ICMJE An Open-label Single Arm Phase 2 Proof of Concept Study to Assess the Efficacy and Safety of ASCT01 in Patients With Critical Limb Ischemia
Brief Summary This study will assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) in patients with critical limb ischemia who have exhausted all medical and surgical therapeutic options. The safety and tolerability will be evaluated by regular monitoring of the general physical condition, vital signs, and the occurrence of AE and SAE, respectively. Furthermore, the standard biochemical and blood variables (red and white blood cell counts, Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin, total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine, immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90 days after the treatment.
Detailed 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Autologous treatment for CLI open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia
Intervention  ICMJE Biological: ASCT01 (Autologous Stem Cell Transplantation)
Single Administration of the entire ASCT01 preparation at rate if 10million CD45+ cells per milliliter at 5 ml per minute via the intra- via intra-arterial infusion route and 6 or more injections of approximately 0.2 ml each intramuscular route
Study Arms  ICMJE ASCT01
ASCT01 (Autologous Stem Cell Transplantation)
Intervention: Biological: ASCT01 (Autologous Stem Cell Transplantation)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and Female patients in the age group of 18-80yrs.
  2. Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
  3. 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
  4. No surgical or interventional option for revascularization and no response to best standard care delivered as confirmed by a vascular surgeon and/or physician.
  5. No immediate life-threatening complication from CLI which would demand immediate amputation.
  6. 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.
  7. On optimal medical therapy
  8. If diabetic, HgbA1c <10%

Exclusion Criteria:

  1. Acute life threatening complication of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
  2. Patients with confirmed Rutherford 6 condition with extensive tissue damage
  3. Patients with documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 6 months.
  4. Patients with a history of severe alcohol or drug abuse within 3 months of screening.
  5. Known bone marrow diseases which preclude transplantation.
  6. End-stage renal failure on regular dialysis treatment. Creatinine ≥2.0 mg/dl
  7. Patients already enrolled in another investigational drug trial or completed within 1month.
  8. Pregnancy.
  9. Patients tested positive for HIV screen1or2, Hepatitis C antibody Hepatitis B surface-antigen, HepatitisBcore Antibody, Syphilis screen
  10. Myocardial infarction / CVA / TIA within the past three months prior to enrollment
  11. Revascularization procedure in target limb within 6 weeks prior to enrollment
  12. Laboratory values as show below*
  13. Currently taking immunosuppressive agents
  14. If diabetic, diagnosis of proliferative retinopathy
  15. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867190
Other Study ID Numbers  ICMJE IND 15069
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lifecells, LLC.
Study Sponsor  ICMJE Lifecells, LLC.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul T Sudhakar, MS, Pharm Lifecells, LLC.
PRS Account Lifecells, LLC.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP