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Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558908
Recruitment Status : Unknown
Verified March 2012 by Medistem Inc..
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2012
Last Update Posted : March 20, 2012
Information provided by (Responsible Party):
Medistem Inc.

Tracking Information
First Submitted Date  ICMJE March 18, 2012
First Posted Date  ICMJE March 20, 2012
Last Update Posted Date March 20, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2012)
Safety [ Time Frame: 52 weeks ]
Adverse and serious events recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2012)
Efficacy [ Time Frame: 12 weeks ]
Improvements post-treatment in rest pain (VAS), toe pressure and ABI, transcutaneous oximetry and ulcer status (with picture).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia
Official Title  ICMJE Allogeneic,Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like, Endometrial Cells; Administered Intramuscular
Brief Summary This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based interventions. Three doses of ERC will be examined. The hypothesis is that ERC administration will be well-tolerated and possibly induce a therapeutic benefit.
Detailed Description

The purpose of the trial is to determine safety of intramuscularly derived menstrual mesenchymal stem cells (otherwise known as Endometrial Regenerative Cells, or ERC) in patients with critical limb ischemia ineligible for revascularization. Safety will be defined as freedom from treatment associated adverse events. Efficacy parameters will comprise endpoints of changes in ankle-brachial index, toe-brachial index, TcPO2, ulcer healing, rest pain, quality of life, and reduction in amputation.

Patients will receive 25, 50, or 100 million menstrual derived mesenchymal stem cells (Endometrial Regenerative Cells: ERC) in ten injections of 2.5, 5, or 10 million mesenchymal stem cells suspended in a volume of 1 ml per injection. Injections will be spaced at least 2 centimeters apart from each other in the gastrocnemius muscle above the failed vascular perfusion area.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Diseases
Intervention  ICMJE Biological: Administration of ERC
Patients will be treated with either 25 million, 50 million, or 100 million ERC by intramuscular injection.
Study Arms  ICMJE Experimental: Intramuscular injection of ERC
Intervention: Biological: Administration of ERC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 18, 2012)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Non-pregnant patients with critical limb ischemia, Rutherford IV-V, manifested as rest pain or tissue loss, or with disabling claudication, manifested as exercise induced thigh or calf pain that impairs activities of daily living, who are not candidates for surgical bypass or angioplasty due to unfavorable arterial anatomy or absence of adequate autogenous vein for a below-knee bypass.
  2. Patients over 18 years of age with an expected survival of more than one year after treatment.
  3. Unreconstructable arterial disease will be determined by a vascular surgeon who is not participating in the study. Unreconstructable arterial disease is defined by atherocclusive lesions within the arterial tree of the extremity that due to extent or morphology are not amenable to surgical bypass or PTCA and stenting.
  4. Patients with a maximum of 3 non-healing 'flat' surface or 'transdermal' ulcers Grades 1-2, no ulcer bigger than 2 centimeters (2)
  5. Patients with unfavorable anatomy or who are medically unfit to undergo bypass as determined by a vascular surgeon who is not participating in the study.
  6. Vascular imaging (eg angiogram or MRA) to determine vascular anatomy must be conducted within 3 months of study entry.
  7. Patients with low/absent perfusion in the area at or below the gastrocnemius muscle
  8. Objective evidence of severe peripheral arterial disease will include an ankle brachial index (ABI) of less than 0.55, and/or a resting toe brachial index (TBI) of less than 40.
  9. Patients must be competent to give consent.
  10. No history of malignant disease except for nonmelanoma skin cancer, no suspicious findings on chest x-ray, mammography (women over age 35) , Papanicolaou smear (women over age 40), a normal fecal occult blood (over age 50) and a normal prostate specific antigen (men over age 45).
  11. Patients must have a prothrombin Time (PT) between 12-14 seconds, a partial thromboplastin time (PTT) of 18-28 seconds, and platelet count >100,000/microliter
  12. Patients must have white blood cell count (4.1-10.9x10(3) cells/µL)
  13. Normal liver function tests (AST 8 - 20 U/L, ALT 8 - 20 U/L, and total bilirubin 0.1 - 1.0 mg/dL)
  14. Patients must be male or post menopausal women.

Exclusion Criteria:

  1. Patients with evidence of active proliferative retinopathy.
  2. Patients with poorly controlled diabetes mellitus (HbA1C > 8.5%).
  3. Patients with renal insufficiency (Creatinine > 2.5) or failure.
  4. Infection as evidenced by WBC count of >15,000 k/cumm and/or temperature >38C.
  5. Cellulitis in the afflicted limb that in the opinion of the investigators would require the use of antibiotics or evidence of osteomyelitis corroborated by radiographic or scintigraphic examination.
  6. Pregnant women (women capable of childbearing must have a negative pregnancy test)
  7. Cognitively impaired adult
  8. Lower extremity venous disease with pitting edema.
  9. History of organ transplant.
  10. Patients with ulcer exudates, dry gangrene or exposed bone.
  11. Allergies to beta-lactam antibiotics, amphotericin B, or streptomycin
  12. Cardiovascular conditions:

    • Exercise limiting angina (Canadian Cardiovascular Society Class > 3
    • Congestive heart failure (New York Heart Association class > 3
    • Unstable angina
    • Acute ST elevation myocardial infarction (MI) within 1month
    • Transient ischemic attack or stroke within 1 month
    • Severe valvular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01558908
Other Study ID Numbers  ICMJE MEDS-027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medistem Inc.
Study Sponsor  ICMJE Medistem Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael P Murphy, MD Indiana University
PRS Account Medistem Inc.
Verification Date March 2012

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