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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Medistem Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Medistem Inc.
ClinicalTrials.gov Identifier:
NCT01558908
First received: March 18, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Biological: Administration of ERC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic,Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like, Endometrial Cells; Administered Intramuscular

Resource links provided by NLM:


Further study details as provided by Medistem Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Adverse and serious events recorded


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvements post-treatment in rest pain (VAS), toe pressure and ABI, transcutaneous oximetry and ulcer status (with picture).


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intramuscular injection of ERC Biological: Administration of ERC
Patients will be treated with either 25 million, 50 million, or 100 million ERC by intramuscular injection.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558908

Contacts
Contact: Michael P Murphy, MD 317-630-8288 mipmurph@iupui.edu
Contact: Janet Klein, RN (317) 962-0287 jswklein@iupui.edu

Locations
United States, Indiana
Indiana University School of Medicine Not yet recruiting
Indianapolis, Indiana, United States
Contact: Michael P Murphy, MD    317-630-8288    mipmurph@iupui.edu   
Principal Investigator: Michael P Murphy, MD         
Sponsors and Collaborators
Medistem Inc.
Investigators
Principal Investigator: Michael P Murphy, MD Indiana University
  More Information

Additional Information:
No publications provided

Responsible Party: Medistem Inc.
ClinicalTrials.gov Identifier: NCT01558908     History of Changes
Other Study ID Numbers: MEDS-027
Study First Received: March 18, 2012
Last Updated: March 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medistem Inc.:
critical limb ischemia

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014