Placental Cells for Diabetic Foot Ulcers

Официальное название

Phase 1 Safety Trial of Placental Stem Cells (PLSC) to Accelerate the Healing of Diabetic Foot Ulcers

Обзор

The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.

Подробное описание

This is a prospective, non-randomized, single institution, Phase 1 safety trial to evaluate the safety of placental stem cells and the rate of diabetic foot ulcer healing in a population of subjects with non-healing diabetic foot ulcers for at least 4 weeks. The trial will also explore the clinical outcomes of placental stem cells treatment on diabetic peripheral neuropathy. Furthermore, the trial will evaluate the effect of the placental stem cells on serum biomarkers associated with diabetic foot ulcers and diabetic peripheral neuropathy (measured pre- and post-treatment) and correlate the biomarker levels with any changes in diabetic foot ulcers and diabetic peripheral neuropathy. Twelve adult subjects with non-healing diabetic foot ulcers for at least four weeks from diagnosis and not more than 12 months with wound sizes ≥ 2 cm2 and ≤ 4 cm2 will be recruited and treated. Subjects will be followed for 12 months after treatment.

Вмешательства

• Препарат Placenta Stem Cells
  Injection of 30 M placenta stem cells into/around the diabetic foot ulcer and along the anterior and posterior tibial arteries of the index leg.

Первичные конечные точки

• Number of Injection Sites Bleeding [Срок оценки: Month 1]
• Number of Injection Sites Bleeding [Срок оценки: Month 3]
• Number of Injection Sites Bleeding [Срок оценки: Month 6]
• Number of Injection Sites Bleeding [Срок оценки: Month 12]
• Number of Injection Sites infection/inflammation [Срок оценки: Month 1]
• Number of Injection Sites infection/inflammation [Срок оценки: Month 3]
• Number of Injection Sites infection/inflammation [Срок оценки: Month 6]
• Number of Injection Sites infection/inflammation [Срок оценки: Month 12]
• Number of Injection Sites with damage to surrounding tissue [Срок оценки: Month 1]
• Number of Injection Sites with damage to surrounding tissue [Срок оценки: Month 3]

Вторичные конечные точки (1)

• Diabetic Foot Ulcer (DFU) size [Срок оценки: Month 12]

Критерии участия

Критерии включения

• Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year
• Unilateral non-healing Diabetic Foot Ulcer (DFU) > 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and/or compression wrap)
• No new diabetes medication for at least 2 weeks pre-treatment
• Subjects must be willing to avoid steroids for the week prior to procedure day

Критерии исключения

• Clinical signs of active infection requiring systemic antibiotic therapy less than 7 days prior to enrollment.
• Radiographic or clinical evidence of active and untreated osteomyelitis at the target ulcer site. Current use of systemic immunosuppressive therapy, including chronic corticosteroids (equivalent to >10 mg/day prednisone for >14 days).
• Hemoglobin (Hgb) A1C >12.0 at screening or time in range for the blood glucose level (TIR) less than 30%. Hb A1c should not be used for patient with hypoalbuminemia or anemia in the past 3 months and for patients with Chronic Kidney disease stage 4. For patients who have Continuous Glucose Monitor (CGM), instead of Hb A1c, TIR (time in range) less than 30 % will be used.
• Patients who are unable / unwilling to tolerate an effective offloading approach. This includes total contact cast, soft felted cast or knee high fracture boot.
• Current alcohol or substance abuse that, in the opinion of the investigators, would interfere with study participation.
• Active malignancy or malignancy related limb amputation.
• Women that are pregnant or planning to become pregnant during the study.
• Patients with albumin levels less than 3.5 or prealbumin levels less than 18.
• Subjects with any conditions that the clinical Investigator believes may jeopardize the safety of the patient to participate in the trial.
• Severe peripheral arterial disease (PAD) (Ankle-Brachial Index (ABI) less than 0.5) or TCOM (Transcutaneous Oximetry Measurement) less than 40 mmHg.
• TWSB > 30 cm2 (total wound surface burden)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT07686094 · IRB00152562

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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