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

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: NCT03509870
Recruitment Status : Terminated (study stopped because of lack of recruitment)
First Posted : April 26, 2018
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

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

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: mesenchymal stromal cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: unblinded single arm intervention
Masking: None (Open Label)
Masking Description: open
Primary Purpose: Treatment
Official Title: Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds'
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
mesenchymal stromal cells
mesenchymal stromal cells in collagen scaffold
Biological: mesenchymal stromal cells
mesenchymal stromal cells in a collagen scaffold




Primary Outcome Measures :
  1. serious adverse events attributable to intervention [ Time Frame: 24 weeks ]
    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


Secondary Outcome Measures :
  1. healing [ Time Frame: 24 weeks ]
    time to complete wound closure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Life expectancy of less than 12 months.
  2. Patients with a definite diagnosis of any immunodeficiency disorder.
  3. 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)].
  4. Active, uncontrolled connective tissue disease.
  5. Renal failure as defined by serum creatinine > 220 µmol/L.
  6. Liver function tests that are > 2.0 times Upper Limit Normal.
  7. Poor nutritional status as measured by serum albumin < 30 g/L.
  8. 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).
  9. Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs).
  10. Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot.
  11. 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.
  12. 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.
  13. 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.
  14. 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).
  15. Any unstable medical condition judged by the Principal Investigator that would cause the study to be detrimental to the patient.
  16. Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
  17. Wounds with an aetiology not related to diabetes.
  18. More than three wounds on the target lower extremity.
  19. The wound to be studied not anatomically distinct from another wound(s) (separated by < 1 cm from another wound or would interfere with standard of care treatment of another wound. Only one single wound per one study subject can be treated in this study.
  20. Wounds which decrease in area by > 50% during the screening 4-week run-in period.
  21. Ulcers with underlying osteomyelitis on the leg with the wound to be treated.
  22. Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
  23. Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
  24. Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
  25. Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
  26. Received dermal substitute or living skin equivalent within 30 days prior to signing the informed consent form.
  27. Received prior (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form.
  28. Has known history of clinical sensitivity reactions to products of bovine origin or to the primary or secondary dressings used in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509870


Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Leiden University Medical Center
Investigators
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Principal Investigator: Peter Rossing, MD Steno Diabetes Center Copenhagen
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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03509870    
Other Study ID Numbers: 2015-005580-16
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Steno Diabetes Center Copenhagen:
diabetes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases