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Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers

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.
 
ClinicalTrials.gov Identifier: NCT01686139
Recruitment Status : Unknown
Verified January 2016 by Dr. Itzhak Siev-Ner, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2012
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Itzhak Siev-Ner, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 17, 2012
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)		 Frequency of Adverse Events [ Time Frame: 6 months after treatment ]
Frequency and severity of Adverse Events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2012)		 Healing of all wounds in the target limb [ Time Frame: 6 months after treatment ]
Healing of all wounds in the target limb (percentage of wound size reduction). Measurements of wound size and wound grading using the University of Texas Diabetic Wound Classification scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 12, 2012)		 Reduced pain [ Time Frame: 6 months after treatment ]
Reduced pain, measured by VAS scale and use of analgesics.
 
Descriptive Information
Brief Title  ICMJE Safety Study of Stem Cells Treatment in Diabetic Foot Ulcers
Official Title  ICMJE Phase 1 Study: Treatment of Patients With Diabetic Foot Complications With Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells (ABMD-MSC)
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type I Diabetes Mellitus With Ulcer
  • Type II Diabetes Mellitus With Ulcer
Intervention  ICMJE Biological: ABMD-MSC
10-20 x 10^6 cells/20mL
Study Arms  ICMJE 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).

Intervention: Biological: ABMD-MSC
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2015)		 12
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2012)		 20
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 81 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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686139
Other Study ID Numbers  ICMJE SHEBA-11-8802-IS-SMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr. Itzhak Siev-Ner, Sheba Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheba Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Itzhak Siev-Ner, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date January 2016

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