Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds

NCT03509870 | Terminated Phase 1 DMC

• 1 other identifier: 2015-005580-16
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers

Conditions

Diabetic Foot Ulcer

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

• serious adverse events attributable to intervention

  1. Death 2. Septicaemia 3. Amputation of the limb administered with therapy 4. Worsening of the ulcer of the limb administered with therapy 5. Allergic reaction or anaphylaxis 6. Abnormal laboratory results 7. Local or systemic reaction requiring hospital admission

  24 weeks

Secondary Outcomes (1)

• healing

  24 weeks

Study Arms (1)

mesenchymal stromal cells

OTHER

mesenchymal stromal cells in collagen scaffold

Biological: mesenchymal stromal cells

Interventions

mesenchymal stromal cells BIOLOGICAL

mesenchymal stromal cells in a collagen scaffold

mesenchymal stromal cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease).
• HbA1c ≤ 97 mmol/mol (≤ 11%).
• Males or non-pregnant females.
• Understand trial information document.
• Provide written informed consent.
• Duration of (diabetic foot) wound \> 4 but \< 52 weeks.
• Reduction of \< 50% area over 4 weeks despite standard care (standard care; off-loading, weekly debridement, dressings, orthotic).
• Wound area with sharp debridement of ≥ 0.5 but ≤ 4.0 cm2.
• Clinically non-infected wound.
• Texas wound stage 1a, 1c or 2a.
• Location of wound below malleolus.
• Affected limb toe pressure ≥ 40 mmHg.
• An ankle-brachial systolic pressure index between 0.7 and 1.3.
• Diagnosis of peripheral neuropathy using American Diabetes Association guidelines (monofilament/vibration sensation/biothesiometer).

You may not qualify if:

• Life expectancy of less than 12 months.
• Patients with a definite diagnosis of any immunodeficiency disorder.
• Viral hepatitis \[patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)\].
• Active, uncontrolled connective tissue disease.
• Renal failure as defined by serum creatinine \> 220 µmol/L.
• Liver function tests that are \> 2.0 times Upper Limit Normal.
• Poor nutritional status as measured by serum albumin \< 30 g/L.
• Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
• Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs).
• Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot.
• Treatment with any systemic corticosteroid immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity to be treated within 30 days prior to signing the informed consent form.
• Having received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study.
• A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance.
• History of non-compliance with treatment or clinical visit attendance (i.e. this study requires that patients will comply with the protocol and ulcer care regimen).
• Any unstable medical condition judged by the Principal Investigator that would cause the study to be detrimental to the patient.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Leiden University Medical Center: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Peter Rossing, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: unblinded single arm intervention

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 26, 2018
• Study Start: June 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

DK (1)