Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

January 26, 2016 updated by: Dr. Itzhak Siev-Ner, Sheba Medical Center

Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)

Diabetes Mellitus (DM) can be regarded as one of the "epidemics" of the western world.

DM contributes to severe morbidity and mortality due to damage in the target organs (neuropathy, vasculopathy, nephropathy, retinopathy).

It affects the quality of life of the patients because of increased rate of blindness, IHD, stroke, end stage renal failure, hemodialysis and lower limb amputations (LLA).The Diabetic Foot (DF) is defined as destruction or infection of tissue/s in the foot of diabetic patients due to neurological damage and / or different levels of Peripheral Vascular Disease (PVD). Diabetic foot complications are the most common cause of lower extremity amputations in the industrialized world. The lifetime occurence of Diabetic Foot Ulcers (DFU) is 20% in diabetic patients.

Between 15% - 25% of the foot ulcers will lead to lower limb amputations.

It has been shown that Mesenchymal Stem Cells (MSCs) could be an effective therapy for many diseases including acute respiratory distress syndrome, spinal cord injury, liver injury and critical limb ischemia.

Stem cells can be obtained from either the patient (autologous) or non-related healthy donors (allogeneic).

The purpose of this study is to determine the safety and efficacy of cultured Bone Marrow Mesenchymal Stromal Cells (BM-MSCs) from allogeneic donors for treatment of chronic leg wounds of diabetic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Orthopedic Rehabilitation out-patient clinic, Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient signed informed consent.
  • Adult males or females between 18 and 81 years of age with diabetes mellitus type 1 or type 2.
  • Patient has one Diabetic Foot Ulcer (DFU) on the treated leg. The size of the DFU is no greater than 10 cm2 .
  • The Diabetic Foot Ulcer (DFU) is neuropathic: The patient is checked by a 5.27 mm Monofilament, and doesn't have a sensation in at least 4 of 9 points in the foot.
  • No endovascular or surgical interventions are planned.
  • Patient isn't in an immediate life threat.

  • Normal organ and marrow function as defined:

    1. Leukocytes ≥3,000/μL
    2. Absolute neutrophil count ≥1,500/μL
    3. Platelets ≥140,000/μL
    4. AST (SGOT)/ALT (SGPT) ≤2.5 X institutional standards range
    5. Creatinine ≤ 2.5 mg/dL
  • Patients with controlled blood pressure (defined as a systolic blood pressure ≤180 and/or a diastolic blood pressure of ≤110 mmHg) and established anti-hypertensive therapy as necessary prior to entry into the study.

Exclusion Criteria:

  • Patient weight is greater than 120 Kg.
  • Patients with poorly controlled diabetes mellitus (HbA1c > 10%).
  • Presence of osteomyelitis (stage B grade 3 and stage D grade 3 on the UT Scale).
  • More than one ulcer in the treated foot.
  • Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment.
  • Patients with ABI <= 0.3
  • Patients receiving treatment with hematopoietic growth factors.
  • (Actively) infected ulcer.
  • Infection of the involved extremity(ies) in the intended region of injection. Patient will be included (injected) if there is a safe zone of 10 cm from any soft tissue infection, manifested by fever, purulence and severe cellulitis.
  • Active wet gangrenous tissue.
  • Patients who require uninterrupted anticoagulation or anti-platelet therapy [i.e. anticoagulation therapy (e.g. Coumadin) that cannot be stopped for 72 hours prior to intramuscular injections.
  • Patients with a blood clotting disorder not caused by medication.
  • Patients with known cancer undergoing treatment including chemotherapy, radiotherapy or immunotherapy.
  • Patients with end stage renal disease requiring dialysis.
  • Patients who are pregnant or lactating.
  • History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz [150mL] of wine or 12 oz [360mL] of beer or 1.5 oz [45mL] of hard liquor) within 6 months of screening and/or history of illicit drug use.
  • Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process.
  • Patients receiving experimental medications or participating in another clinical study within 30 days of screening.
  • Immune deficient patients.
  • Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or Syphilis at the time of screening.
  • Patients treated by Ilomedin (Iloprost).
  • Patients having received a new chronic pharmacologic treatment regimen within 4 weeks prior to enrollment.
  • Patients undergoing hyperbaric oxygen treatment within 4 weeks of inclusion and/or required throughout the trial.
  • Concomitant wound treatments that include growth factors or tissue engineered products.
  • In the opinion of the investigator, the patient is unsuitable for cellular therapy.
  • Patients receiving systemic or direct target limb injection of antiangiogenic drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABDM-MSC

The patient will receive multiple injections in one session during the study. The injections will take place in the chronic wound bed and in the third distal part of the treated shin (in the form of a ring).

Maximal amount of ABMD-MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size & patient weight).
Biological: ABMD-MSC
10-20 x 10^6 cells/20mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events
Time Frame: 6 months after treatment
Frequency and severity of Adverse Events.
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Itzhak Siev-Ner, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-11-8802-IS-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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