EUCTR2015-005580-16-DK进行中（未招募）1 期
A Phase 1b, open label, uncontrolled non-randomised single dose study to examine the safety of topically applied bone marrow derived allogeneic mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
招募中
1 期
A Phase I clinical study of KK2260 in patients with advanced or metastatic solid tumorsJPRN-jRCT2031230372Takase Riho139
进行中（未招募）
1 期
Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination with Modified FOLFIRINOX (mFFX) With or Without Budigalimab compared to mFFX in Subjects with Untreated Metastatic Pancreatic Adenocarcinomantreated Metastatic Pancreatic AdenocarcinomaEUCTR2020-005767-31-ESAbbVie Deutschland GmbH & Co. KG129
已完成
1 期
Phase I / II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)COVID-19SARS-CoV-2JPRN-jRCT2051210052Daikyoji Yuichi400
已完成
1 期
Food effect and pharmacokinetics study in healthy, male volunteers with P2202CTRI/2010/091/002992Piramal Enterprises Limited32
已完成
不适用
A phase I/II, partially randomised, open-labelled study of visilizumab in patients with severe ulcerative colitis refractory to intravenous corticosteroidslcerative colitisDigestive SystemUlcerative colitisISRCTN94152325PDL BioPharma Inc. (USA)144