NIPH Clinical Trials Search

An investigator initiated clinical trial to evaluate the safety and efficacy of insulin-producing cells auto-transplantation derived from autologous adipose-derived stem cells in patients with type 1 diabetes mellitus

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Type 1 Diabetes Mellitus
Date of first enrollment	05/01/2026
Target sample size	3
Countries of recruitment
Study type	Interventional
Intervention(s)	A maximum dose of TUFF-IPC, within the range of greater than or equal to 1,100 IE per kg and up to an upper limit of 1,500 IE per kg, will be administered into the mesentery near the ligament of Treitz, in accordance with the intraperitoneal administration procedure. The target dose will be calculated based on the subject's body weight at screening.

Outcome(s)

Primary Outcome	Safety (adverse events and device deficiencies) from the pretreatment stage prior to adipose tissue collection (oral prophylactic antibiotics) through 60 days post-transplantation (laparoscopic transplantation).
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Both
Include criteria	1.Subjects aged 18 years or older and 65 years or younger at the time of obtaining informed consent. 2.Subjects who are able to provide written informed consent for participation in this trial of their own motives. 3.Subjects who are able to comply with the procedures specified in the clinical trial protocol. 4.Subjects who have been in an insulin-dependent state for more than 5 years at the time of obtaining informed consent. 5.Subjects with depleted endogenous insulin secretion, defined as fasting serum C-peptide is less than 0.1 ng/mL. 6.Subjects who are compliant with intensive insulin therapy for diabetes. Intensive insulin therapy is defined as performing frequent self-monitoring of blood glucose averaging at least four times daily over a week, and receiving insulin therapy consisting of four or more daily injections or treatment via an insulin pump. Intensive insulin therapy must have been adjusted under the supervision of a diabetes specialist at a frequency of approximately once per month during the past 12 months. 7.Subjects whose blood glucose control remains extremely difficult despite all therapeutic efforts by a diabetes specialist.1.Subjects with severe heart failure (BNP is greater than or equal to 100 pg/mL). 8.Subjects who have experienced at least one episode of severe hypoglycemic attucks during the past 12 months. Severe hypoglycemic atuck is defined as fulfilling one of the following conditions under appropriate glycemic management: (1) Requiring assistance from another person, with a concomitant blood glucose level of less than or equal to 60 mg/dL. (2) Requiring assistance from another person and recovery achieved through oral carbohydrate intake, intravenous glucose administration, or glucagon administration. 9.Subjects in a condition where pancreas transplantation or islet transplantation should be considered. The condition shall be assessed by a comprehensive evaluation by a diabetes specialist and refers to a state in which quality of life is markedly impaired and anxiety about hypoglycemia is increased due to objective indicators or events. 10.Subjects who have data regarding the Clark score. 11.Subjects who have an adequate system to receive appropriate medical care at home, or those who have family or equivalent support systems that can promptly contact or visit Tokushima University Hospital in the event of health deterioration.
Exclude criteria	1.Subjects with severe heart failure (BNP is greater than or equal to 100 pg/mL). 2.Subjects with liver disease classified as Child-Pugh grade B or higher. 3.Subjects with chronic kidney disease stage G3b or higher (eGFR is less than or equal to 44 mL/min/1.73 m2). 4.Subjects diagnosed by a physician with alcohol dependence (except those with confirmed abstinence by psychiatric evaluation) or drug dependence. 5.Subjects with confirmed active infection (white blood cell count is greater than or equal to 10,000/mm3 and/or serum CRP is less than or equal to1.0 mg/dL). 6.Subjects with a history of malignancy within the past 5 years or in whom recurrence or metastasis cannot be ruled out by imaging or blood tests. 7.Subjects with obesity defined as BMI is greater than or equal to 30. 8.Subjects expected to have severe intra-abdominal adhesions (e.g., history of peritonitis surgery or surgery for ileus). 9.Subjects with portal hypertension or definite liver cirrhosis (abnormal collateral circulation in the mesentery confirmed or suspected on contrast-enhanced CT). 10.Subjects with impaired cardiac function incompatible with laparoscopic surgery (left ventricular ejection fraction is less than 40 percent on echocardiography). 11.Subjects with impaired respiratory function incompatible with laparoscopic surgery (% vital capacity is less than80 percent and/or FEV1.0 percent is less than 70 percent on spirometry). 12.Subjects with severe sarcopenia, defined as: Low skeletal muscle mass: less than 7.0 kg/m2 in men, less than 5.4 kg/m2 in women by DXA; Low muscle strength: grip strength is less than 28 kg in men, less than 18 kg in women; Low physical performance: walking speed less than 1 m/s over 6 meters. 13.Subjects who, in the opinion of a diabetes specialist, are unlikely to show improvement in glucose tolerance even with TUFF-IPC transplantation. 14.Subjects with allergies to local anesthetics or agents used for general anesthesia. 15.Subjects with a history of surgical scars or other skin scarring that would be unacceptable to the subject. 16.Subjects with comorbidities requiring intravenous or oral administration of steroids (however, this does not apply to those receiving topical steroid preparations or local steroid injections for scar treatment, provided they can be discontinued during the perioperative period). 17.Subjects with confirmed or suspected abnormalities in lipid metabolism. 18.Subjects with current or past allergies to the raw materials of the investigational product. 19.Pregnant or breastfeeding women, or women of childbearing potential who test positive for pregnancy at screening. 20.Subjects who are unable to adhere to appropriate contraceptive measures (by both the subject and their partner) from the time of consent until the final examination/observation period, such as oral contraceptives, intrauterine devices, or condom use. 21.Subjects judged by the principal investigator to be otherwise unsuitable for transplantation.