A clinical trial to evaluate the safety and efficacy of the pluripotent stem cell accumulating device (BSM1) and treatment of diabetic foot ulcers using Biiosheets

JRCT ID: jRCT2032230318

Registered date:04/09/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diabetic foot ulcers unhealed with standard treatment or requiring extra-resection of proximal sites
• Date of first enrollment: 05/09/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

1) An incision is made in the skin of the chest or abdomen to create a subcutaneous pocket beneath the dermis layer. The minimum number of BSM1s to be implanted is 2, and the maximum number is 4. The areas of embedding are decided by the investigator according to the physical constitution and wishes of the patient.
2) A sizar is inserted into the created subcutaneous pocket to confirm sufficient space for BSM1 implantation.
3)Sterilized BSM1s are visually inspected their appearance to confirm the absence of abnormality and deformity.
4) Pipe shaped Inserter is inserted into the pocket with a bar as a guide, and then removed the bar.
5) A catheter tube is connected to BSM1.
6) BSM1 is inserted into inserter.
7) Inserter is removed and then BSM1 is left into the subcutaneous pocket.
8) An electric surgical knife is used for hemostasis of the subcutaneous bleeding.
9) Incision is closed by sutures.
10) The air in the BSM1 is carefully sucked through the catheter tube by a syringe. Excessive negative pressure may course the deformity of BSM1.
11) An echo examination is performed to check the excessive fluid and blood solution around the BSM1 requiring needle drainage.
12) Embedding period is at least 3 weeks.
13) BSM1 is taken out of the subcutaneous pocket through the same incision
14) After removing the connective tissue of the outer circumference around the BSM1, Biosheet formed inside the BSM1 is taken out.
15) Biosheets are visually inspected their appearance to check the defects and tears.
16) To confirm the intensity of the Biosheet, both of the edge of the Biosheet, is suspended with two forceps.
17) The weight of the Biosheet is measured.
18) After the preparation of the wound bed by the debridement, Biosheets appropriate to the wound size (about 5 g per 5x5 cm wound size) are pasted.

Outcome(s)

• Primary Outcome: The rate of the patients (examinees) who were able to obtain the Biosheets containing pluripotent stem cells

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Age is over 18 years old
(2) Type 1 or type 2 diabetic mellitus
(3) Having an unhealed diabetic foot ulcer by standard wound treatment
(4) Chronic limb threatening ischemia that meets W-1 to 3, I-0 to 2, fI-0 to 2, and clinical stage 3 or 4 in WIfI classification
(5) Patients correspond to one of the following
a. Foot and/or heal ulcer allow for over 4cm2 wound area after the debridement
b. Foot gangrene allow for the additional resection including the healthy proximal site
(6) Survival of 12 months or more and followed-up for 12 weeks after the treatment are possible.
(7) Agreement for participating in the study and informed consent signed by the patient.

Exclude criteria

(1) Patients who have difficulty in securing the implantation period of the clinical trial equipment required for Biotube formation.
(2) Patients with general condition who are difficult to tolerate surgery due to severe malnutrition and complications.
(3) Patients with poor skin condition who cannot secure more than one implantation site for the investigational device.
(4) Patients undergoing invasive surgery except wound care (debridement) or revascularization within 30 days prior to enrollment
(5) Patients who have a history of allergies to stainless steel or polyolefin resin
(6) Poor control blood sugar level (Fasting blood sugar > 200 mg/dl)
(7) History and complications of malignant tumors (excludes those with no recurrence for more than 5 years after treatment or new onset).
(8) Participating in other clinical trials within 3 months prior to enrollment.
(9) History of experiences of this device or Biosheet
(10) Patients who use immunosuppressants for autoimmune diseases and post-implantation.
(11) Pregnant patients
(12) Large wounds allow for over 25cm2 area after the debridement.
(13) Severe limb ischemia having no options of revascularization or limb ischemia due to vasculitis.
(14) Progressive ulcers, gangrenes, and sepsis allow for major amputation.
(15) Septic conditions (CRP > 5 mg/dl)
(16) Patients judged by the investigator to be inappropriate due to medical conditions or safety reasons.

Related Information

• Primary Sponsor: Higashita Ryuji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development