Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease (ADICROHN3)
2026年6月1日 更新者：Assistance Publique Hopitaux De Marseille
The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.
Its design is supported by the following elements:
- The results of the ADICROHN pilot study (EudraCT No. 2013-002602-31) and our 3-year study, which demonstrate an excellent safety profile with a promising efficacy signal.
- Data from the literature confirming that cryopreservation of FVS does not compromise the clonogenic and differentiation potential of mesenchymal progenitors, nor its regenerative effect.
- The ongoing ADICROHN-2 study (PHRC N 2019; EudraCT No. 2019-001948-21) confirming the feasibility of patient recruitment, mastery of the therapeutic approach, and the absence of adverse events related to the experimental treatment.
- The opportunity for a second FVS injection for patients initially treated but who did not respond to the treatment.
- The opportunity for a first FVS injection in patients in the placebo arm, thereby providing access to an innovative therapy available to patients included in this trial who are untreated and remain refractory to standard care.
To avoid compromising the results of the ongoing ADICROHN-2 study, enrolled patients will remain blinded to the treatment arm to which they belonged in the ADICROHN-2 study.
調査の概要
研究の種類
介入
入学 (推定)
25
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Marseille、フランス
- 募集
- APHM Hôpital Nord
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コンタクト：
- Dr GUILLO
- 電話番号：+33 0491968737
- メール：lucas.guillo@ap-hm.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- (1) Signing of a consent form.
- (2) Patients with Crohn's disease diagnosed at least 6 months prior, in accordance with clinical, endoscopic, histological, and/or radiological criteria.
- (3) Patients previously enrolled in or treated as part of the ADICROHN 2 study.
- (4) Non-active or mildly active luminal Crohn's disease, defined by a CDAI score ≤ 220.
- (5) Patients who failed to respond to the ADICROHN-2 protocol, defined by the persistence of anoperineal fistula(s) at the end of the ADICROHN-2 study and their persistence at the time of enrollment.
- (6) Patients who achieved success (combined remission) at the end of the ADICROHN-2 study but who have a recurrence of anoperineal fistula(s) at the time of enrollment.
- (7) Sufficient quantity of cryopreserved cells to allow for the innovative treatment, based on the number of fistulas to be treated.
- (8) Patients over 18 years of age.
- (9) Good general health based on medical history and clinical examination.
- (10) Women of childbearing age must have a negative pregnancy test (serum or urine; detection threshold: 25 mIU hCG/ml). Patients of both sexes must use a reliable method of contraception.
- (11) Enrollment in a social security program.
Exclusion Criteria:
- (1) Active, primarily luminal Crohn's disease requiring immediate treatment.
- (2) Patients who experienced intolerance to the advanced therapy medicinal product during the ADICROHN-2 study.
- (3) Presence of an abscess or collections > 2 cm at the time of enrollment, unless this issue is resolved during the fistula preparation period.
- (4) Rectal and/or anal stenosis and/or active proctitis resulting in a limitation of the surgical procedure.
- (5) Patients currently receiving corticosteroids or who have received them within the four weeks prior to the injection of the investigational product.
- (6) Malignant tumors or a history of malignant tumors within the past 5 years.
- (7) Congenital or acquired immunodeficiency.
- (8) Contraindications to local anesthetics and gadolinium (MRI contrast agent).
- (9) Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical device or material [e.g., insulin pump], orthopedic medical prostheses.
- (10) Treatment with darvadstrocel administered < 6 months prior to enrollment)
- (11) Contraindications to general anesthesia.
- (12) BMI < 18 kg/m² to ensure an adequate amount of abdominal adipose tissue or other subcutaneous adipose tissue accessible via manual liposuction.
- (13) Coagulation disorders that contraindicate surgery.
- (14) Known hypersensitivity to human albumin.
- (15) Participation in another clinical trial (excluding observational studies).
- (16) Persons protected under Articles L1121-5, L1121-6, and L1121-8 of the Public Health Code (pregnant or breastfeeding women, persons deprived of liberty by judicial decision, persons in situations of social vulnerability, adults who are legally incapacitated or unable to give informed consent).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：treatment arm
injection of thawed SVF
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injection of thawed SVF, collected in ADICROHN 2
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The primary endpoint of the study is the overall safety profile at 6 months
時間枠：6 months
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absence of local infectious complications, defined by the absence of local signs of inflammation: pain, and/or erythematous plaque, and/or swelling or induration.
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6 months
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The primary endpoint of the study is the overall safety profile at 6 months
時間枠：6 months
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absence of systemic infectious complications, defined as the absence of systemic signs of infection: fever, chills, mottling, hypotension.
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6 months
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The primary endpoint of the study is the overall safety profile at 6 months
時間枠：6 months
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absence of any worsening of anal incontinence compared with the pre-treatment assessment, as measured by the Wexner index
|
6 months
|
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The primary endpoint of the study is the overall safety profile at 6 months
時間枠：6 months
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absence of any other adverse events considered to be potentially related to the experimental treatment.
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6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年12月30日
一次修了 (推定)
2028年6月29日
研究の完了 (推定)
2028年6月29日
試験登録日
最初に提出
2026年3月31日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。