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

NCT01558908 | Unknown Phase 1

• 1 other identifier: MEDS-027
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Diseases

Keywords

critical limb ischemia

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse and serious events recorded

  52 weeks

Secondary Outcomes (1)

• Efficacy

  12 weeks

Study Arms (1)

Intramuscular injection of ERC

EXPERIMENTAL

Biological: Administration of ERC

Interventions

Administration of ERC BIOLOGICAL

Patients will be treated with either 25 million, 50 million, or 100 million ERC by intramuscular injection.

Intramuscular injection of ERC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients over 18 years of age with an expected survival of more than one year after treatment.
• 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.
• Patients with a maximum of 3 non-healing 'flat' surface or 'transdermal' ulcers Grades 1-2, no ulcer bigger than 2 centimeters (2)
• 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.
• Vascular imaging (eg angiogram or MRA) to determine vascular anatomy must be conducted within 3 months of study entry.
• Patients with low/absent perfusion in the area at or below the gastrocnemius muscle
• 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.
• Patients must be competent to give consent.
• 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).
• 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
• Patients must have white blood cell count (4.1-10.9x10(3) cells/µL)
• Normal liver function tests (AST 8 - 20 U/L, ALT 8 - 20 U/L, and total bilirubin 0.1 - 1.0 mg/dL)
• Patients must be male or post menopausal women.

You may not qualify if:

• Patients with evidence of active proliferative retinopathy.
• Patients with poorly controlled diabetes mellitus (HbA1C \> 8.5%).
• Patients with renal insufficiency (Creatinine \> 2.5) or failure.
• Infection as evidenced by WBC count of \>15,000 k/cumm and/or temperature \>38C.
• 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.
• Pregnant women (women capable of childbearing must have a negative pregnancy test)
• Cognitively impaired adult
• Lower extremity venous disease with pitting edema.
• History of organ transplant.
• Patients with ulcer exudates, dry gangrene or exposed bone.
• Allergies to beta-lactam antibiotics, amphotericin B, or streptomycin
• Cardiovascular conditions:
• Exercise limiting angina (Canadian Cardiovascular Society Class \> 3
• Congestive heart failure (New York Heart Association class \> 3
• Unstable angina

Sponsors & Collaborators

• Medistem Inc.: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, United States

Location

Related Links

• Murphy et al. Allogeneic endometrial regenerative cells: An "Off the shelf solution" for critical limb ischemia? J Transl Med. 2008 Aug 19;6:45.

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Michael P Murphy, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P Murphy, MD

CONTACT

317-630-8288; mipmurph@iupui.edu

Janet Klein, RN

CONTACT

(317) 962-0287; jswklein@iupui.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (1)