ISRCTN73586959进行中（未招募）2 期
An adaptive, single arm, multi-centre phase IIa multi-disease clinical trial investigating the safety and activity of the use of a single infusion of selected Mesenchymal Stromal Cells (MSC) to reduce liver inflammation in the treatment of patients with primary sclerosing cholangitis and autoimmune hepatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 01/08/2023:
- •Patients with PSC:
- •1. Aged =18 years at visit 1 (screening)
- •2. Diagnosis of PSC at visit 1 (screening) as evidenced clinically by:
- •2.1. Chronic biochemical cholestasis (elevated serum alkaline phosphatase (ALP) above the
- •upper limit of normal (ULN) and/or gamma-glutamyl transpeptidase (GGT) above the ULN) > 6 months duration AND
- •2.2. Radiological AND/OR histological evidence of clinically documented PSC
- •3. Serum ALP) = 1.5 ULN at visit 1 (screening)
- •4. Any Serum ALP value change is <40% using two sets of laboratory values obtained during screening. If a participant fails to confirm an ALP at Visit 2 that is within 40% of the ALP at Visit 1, a further screening ALP (Visit 2a) can be arranged, so long as the variation in ALP was <50%, and the Principal Investigator has no other clinical reason to suggest the patient is clinically unstable. If the ALP is within 40% variance at Visit 2a as compared to Visit 1, Trial registration is permitted.
- •5. At Visit 2 (and Visit 2a if applicable), it should be confirmed that a patient does not meet any of the exclusion criteria
- •Patients with AIH
- •1. Aged =18 and =70 years at visit 1 (screening)
- •2. Established pre-existing clinical diagnosis of AIH confirmed by clinical expert review consistent with the simplified IAIHG criteria (http://www.mdcalc.com/simplified-scoring-autoimmune-hepatitis-aih/) and must include history of a liver biopsy reported compatible with AIH
- •3. Active AIH defined by ALT =1.1x ULN
- •4. Serum ALT must be above =1.1x ULN at both screening (visit 1) and visit 2
- •5. At visit 2, it should be confirmed that a patient does not meet any of the exclusion criteria
- •6. Patients must be on standard-of-care AIH treatment for =24 weeks – this includes any AIH therapy except biologics
- •7. Stable doses of immunosuppression for a minimum period of 4 weeks at the time of screening, and no planned change in immunosuppression for the course of the trial
- •Previous inclusion criteria as of 28/04/2021:
- •Patients with PSC:
- •1. Aged =18 years at visit 1 (screening)
- •2. Diagnosis of PSC at visit 1 (screening) as evidenced clinically by:
- •2.1. Chronic biochemical cholestasis (elevated serum alkaline phosphatase (ALP) above the upper limit of normal (ULN) and/or gamma-glutamyl transpeptidase (GGT) above the ULN) > 6 months duration AND
- •2.2. Radiological AND/OR histological evidence of clinically documented PSC
- •3. Serum ALP) = 1.5 ULN at visit 1 (screening)
- •4. Any Serum ALP value change is <40% using two sets of laboratory values obtained during screening. If a participant fails to confirm an ALP at Visit 2 that is within 40% of the ALP at Visit 1, a further screening ALP (Visit 2a) can be arranged, so long as the variation in ALP was <50%, and the Principal Investigator has no other clinical reason to suggest the patient is clinically
- •unstable. If the ALP is within 40% variance at Visit 2a as compared to Visit 1, Trial registration is permitted.
- •5. At Visit 2 (and Visit 2a if applicable), it should be confirmed that a patient does not meet any of the exclusion criteria
- •Patients with AIH
- •1. Aged =18 and =70 years at visit 1 (screening)
- •2. Established pre-existing clinical diagnosis of AIH confirmed by clinical expert review consistent with the simplified IAIHG criteria (http://www.mdcalc.com/simplified-scoring-autoimmune-hepatitis-aih/) and must include history of a liver biopsy reported compatible with AIH
- •3. Active AIH defined by ALT =1.5x ULN
- •4. Serum ALT mus
排除标准
- •Current exclusion criteria as of 28/04/2021:
- •Generic exclusion criteria that will apply to both patients with PSC and AIH:
- •1. Refusal or lacks capacity to give informed consent to participate in trial
- •2. Patient who is unable to participate in follow-up assessment
- •3. Participation actively, or within five half-lives, of another interventional clinical trial
- •4. Known hypersensitivity to the investigational product or any of its formulation excipients
- •5. Evidence of active malignancy (within 3 years of Visit 1), other than non-melanoma skin cancer and cervical dysplasia in situ
- •6. Major surgical procedure within 30 days at Visit 1
- •7. Prior organ transplantation
- •8. Active harmful alcohol consumption as evaluated and documented by the Investigator
- •9. Poor venous access therefore unable to support a 22G needle for infusion
- •10. Creatinine > 133 µmol/L or being treated with renal replacement therapy at the time of Visit 1
- •11. AST or ALT >10x ULN
- •12. ALP >10x ULN
- •13. Platelets <50 x 10(9)/l
- •14. Total Bilirubin >2x ULN
- •15. INR >1.3 (in the absence of concomitant use of Warfarin or equivalent anti-coagulant therapy)
- •16. Albumin <35 g/l
- •17. Haemoglobin <10 g/dl
- •18. Past or present evidence of decompensated chronic liver disease:
- •18.1. Radiological or clinical evidence of ascites
- •18.2. Hepatic encephalopathy
- •18.3. Endoscopic evidence for portal hypertensive bleeding
- •19. Any active treatment with biologic therapy (monoclonal antibodies)
- •20. Clinically severe cardiovascular disease as evaluated by the Investigator
- •21. Pregnancy or breast-feeding
- •22. Women of child bearing potential who are unwilling to practice effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the trial up to 90 days after the trial drug is administered. If using hormonal agents the same method must have been used for at least 1 month before study dosing and patients must use a barrier method during that time period.
- •23. Non-vasectomised men, sexually active with women of child bearing potential, who are not willing to practice effective contraception (condom with spermicide) for the duration of the trial up to 90 days after the trial drug is administered
- •24. Patients with a history of hepatitis C (present or past infection), known positivity for antibody to HIV or any evidence of current or past hepatitis B virus (HBV) infection
- •25. Presence of an acute/chronic infection or illness that, at the discretion of the Investigator, might compromise the patient’s health and safety in the trial
- •26. Any symptoms indicative of COVID-19; including fever, chronic/persistent cough, or loss of sense of taste or smell in the preceding 2 weeks
- •27. Receipt of live vaccination within 6 weeks prior to Visit 1
- •Exclusion criteria specific to patients with PSC:
- •1. Documented alternative aetiology for sclerosing cholangitis (i.e. secondary sclerosing cholangitis)
- •2. A dominant (as determined by Investigator) alternative chronic or active liver injury other than PSC at the time of Visit 1; patients with possible overlap syndrome with AIH are excluded from the PSC cohort if the Investigator considers AIH as the dominant liver injury
- •3. UDCA dose modification within the last 90 days
- •4. ALP >10x ULN
- •5. Evidence of cholangitis within 90 days of Visit 1:
- •5.1. Documented evidence of cholangitis by physician
- •5.2. Need for any antibiotics for presumed cholangitis
- •6. Any patient taking prophylactic antibi
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