試験ID jRCT2063250055
最終情報更新日：2026年5月10日
１型糖尿病患者に対する自己脂肪由来幹細胞由来インスリン産生細胞移植による安全性及び有効性を検討する医師主導治験（第I/IIa相試験）（FIH試験）
基本情報
| 試験ID | jRCT2063250055 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | １型糖尿病患者に対する自己脂肪由来幹細胞由来インスリン産生細胞移植による安全性及び有効性を検討する医師主導治験（第I/IIa相試験）（FIH試験） | 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 |
| 平易な研究名称 / Public Title（Acronym） | 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 | |
| 試験進捗状況/Recruitment status | Recruiting | |
| 登録日時 | 2025年9月18日 | |
| 最終情報更新日 | 2026年5月10日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
試験概要
| 試験実施地域 / Region | 日本 | |
|---|---|---|
| 実施都道府県 | 徳島県 | |
| 目標症例数/Target sample size | 3 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 1型糖尿病 | Type 1 Diabetes Mellitus |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | 1,100 IE/kg以上、1,500 IE/kgを上限として、TUFF-IPCを投与可能な最大量を腹腔投与に準じてトライツ靭帯付近の腸間膜内に投与する。目標投与量の算出には、スクリーニング時の体重を用いるものとする。 | |
| 介入2 | 1,100 IE/kg以上、1,500 IE/kgを上限として、TUFF-IPCを投与可能な最大量を腹腔投与に準じてトライツ靭帯付近の腸間膜内に投与する。目標投与量の算出には、スクリーニング時の体重を用いるものとする。 | |
| 主要評価項目 / Primary outcomes | 脂肪組織採取前処置段階（予防的抗菌薬内服）から移植後（腹腔鏡下移植）60日以内までの安全性（有害事象及び不具合） | 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). |
| 副次評価項目 / Secondary outcomes | 安全性： 脂肪組織採取前処置段階（予防的抗菌薬内服）から移植後（腹腔鏡下移植）360日目までの安全性（有害事象及び不具合） ?有効性： ・血清C-peptide（移植後30日目及び60日目、120日目、180日目、360日目及び中止時に空腹時血清C-peptide ≧0.3 ng/mLとなった場合を生着とする） ・インスリン要求量の減少 ・血糖自己測定（Self-Monitoring Blood Glucose (SMBG):1日7回（毎食前、毎食後2時間、眠前）） ・持続血糖モニタリング（Continuous Glucose Monitoring: CGM） ・アンケート調査 1) 低血糖の無自覚性評価：Clark score 2) 低血糖への不安の調査：Hypoglycemia Fear Survey（HFS-B, HFS-W） 3) 糖尿病治療満足度質問票：Diabetes Treatment Satisfaction Questionnaire (DTSQ) ・抗GAD抗体、抗IA-2抗体、抗ZnT8A抗体の各抗体価 | |
適格性
| 年齢（下限）/ Age minimum | 18歳以上 | >= 18age old |
|---|---|---|
| 年齢（上限）/ Age maximum | 65歳未満 | <= 65age old |
| 性別 / Gender | 男女両方 | Both |
| 選択基準 / 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. | |
| 除外基準 / 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. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Tetsuya Ikemoto | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Tokushima University Hospital | |
| 住所 / Address | 2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima, Japan Tokushima Japan 770-8503 | |
| 電話 / Telephone | +81-88-633-9658 | |
| 実施責任組織 / Affiliation | 池本 哲也 | Tokushima University Hospital |
| 研究費提供組織 / Funding Source | ||
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | 2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima, Japan Tokushima Japan 770-8503 | |
|---|---|---|
| 電話 / Telephone | +81-88-633-9658 | |
| ホームページURL | ||
| tuffipc_mado@tokushima-u.ac.jp | ||
| 担当者 / Name of contact person | Coordinating Center TUFF-IPC |
倫理審査委員会
| 認定臨床研究審査委員会又は倫理審査委員会の名称 | ||
|---|---|---|
| 上記委員会の認定番号 | 住所 / Address | |
| 電話番号 | ||
| 審査受付番号 | ||
| 当該臨床研究に対する審査結果 | ||
| 認定臨床研究審査委員会の承認日 | ||
変更・中止の場合
| 中止届出日 | ||
|---|---|---|
| 中止年月日 | ||
| 中止の理由 | ||
終了の場合
| 終了届出日 | ||
|---|---|---|
| 観察期間終了日 | ||
| 実施症例数 | ||
| 参加者の流れ（Participant flow） | ||
| 研究対象者の背景情報 | ||
| 疾病等の発生状況のまとめ | ||
| 主要評価項目及び副次評価項目のデータ解析及び結果 | ||
| 公開予定日 | ||
| 要約 | ||
| 研究実施計画書のURL | ||
| 結果に関する最初の出版物での発表日 | ||
| 結果と出版物に関するURL | ||
IPD data sharing
| 個々の研究対象者単位のデータ（IPD）を共有する計画 | ||
|---|---|---|
| 計画の説明 | ||