A Phase 1b, open label, uncontrolled non-randomised single dose study to examine the safety of topically applied stem cells (REDDSTAR ORBCEL-M) to patients with non-healing diabetic foot wounds

Phase 1

• Conditions: Patients with non-healing neuroischaemic diabetic foot wounds; MedDRA version: 19.0Level: LLTClassification code 10012664Term: Diabetic foot ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-005580-16-DK
• Lead Sponsor: Steno Diabetes Center A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-09
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9

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 = 40mmHg; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms).
14. An ankle-brachial systolic pressure index between 0.7 and 1.3.
15. Diagnosis of peripheral neuropathy using ADA guidelines (monofilament/vibration sensation/biothesiometer).
16. Adhere to study visit protocol.
17. Adhere to offloading devices/orthotic.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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 (e.g. AST, ALT) that are > 2.0 times ULN.
7. Poor nutritional status as measured by serum albumin < 30 mg/dL.
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 Investigator or Medical Monitor that would cause the study to be detrimental to the patient.
16. A Haemoglobin A1c (HbA1c) test result of > 11% (>97 mmol/mol) documented at the screening visit.
17. Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
18. Wounds with an aetiology not related to diabetes.
19. More than three wounds on the target lower extremity.
20. 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.
21. Wounds which decrease in area by >50% during the screening 4-week run-in period.
22. Ulcers with underlying osteomyelitis on the leg with the wound to be treated.
23. 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).
24. Revascularization surgery on the leg with the wound to be treated =8 weeks prior to signing the informed consent form.
25. Surgery to lengthen Achilles tendon on the leg with the wound to be treated =8 weeks prior to signing the informed consent form.
26. Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
27. Received dermal substitute or living skin equivalent (Leukopatch within 30 days prior to signing the informed consent form.
28. Received prior PDGF-BB (Regranex®/becaplermin) therapy within 30 days prior to

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified