Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2017-12-11
2024-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Bone marrow-derived Mesenchymal Stromal Cells
Mesenchymal Stromal Cells
Cells will be administered intravenously at 3 different doses (80, 160, or 240 x 10\^6, fixed dose) over 10-20 minutes. Volume total of fluid infused: 40 ml
Cryostor CS10
Placebo
Volume total of fluid infused: 40 ml
Interventions
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Mesenchymal Stromal Cells
Cells will be administered intravenously at 3 different doses (80, 160, or 240 x 10\^6, fixed dose) over 10-20 minutes. Volume total of fluid infused: 40 ml
Placebo
Volume total of fluid infused: 40 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* T2D for 3 or more years under a clinician with mandated responsibility for management of the patients to national guidelines;
* Urinary albumin excretion (UAE) ≥ 60 µg/min (in a 24 hour urine collection) and urine albumin-to-creatinine ratio (UACR) ≥ 88 mg/g (≥ 10 mg/mmol) (in a spot morning urine collection);
* Estimated GFR (eGFR) 30-50 ml/min/1.73 m\^2 by the CKD-EPI equation on 2 or more consecutive measurements at least 30 days apart within the past 6 months;
* A documented decline of eGFR of ≥ -10ml/min/1.73 m\^2 over the past 3 years or documented rate of eGFR decline of ≥ -5 ml/min/1.73 m\^2 year based on 3 or more consecutive readings at least 90 days apart in the past 18 months;
* Lack of suspicion of renal diagnosis other than DKD;
* Willing and able to provide written informed consent.
Exclusion Criteria
2. Initiation of a new anti-hypertensive agent within the past 6 months
3. Increase the dose of an anti-hypertensive agent by ≥ 100% of the previous dose within the past 3 months
4. Current HbA1c \> 75 mmol/mol (\> 9%)
5. Initiation of a new hypoglycaemic agent within the past 6 months
6. Increase the dose of a hypoglycaemic agent by ≥ 100% of the previous dose within the past 3 months
7. Current fasting total cholesterol \> 7 mmol/l
8. Current fasting total triglycerides \> 3.5 mmol/l
9. Initiation of a new lipid lowering agent within the past 6 months
10. Chronic lung or liver disease;
11. Cardiovascular events (myocardial infarction, stroke or acute limb ischemia) within 6 months prior to enrolment;
12. Current or history within 6 months prior to enrolment of NYHA class III or IV heart failure;
13. Other concomitant disease or conditions in the opinion of the investigator that are likely to pose risk to the patient and that would render the patient unsuitable for participation or that could impair patient safety or ability to participate in the study, such as active malignancy;
14. Irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
15. Positive screening test for clinically significant anti-HLA antibodies. An initial antibody screening with Luminex® multi-antigen beads to detect class I and class II MHC antibodies followed by a Luminex single antigen bead assay to determine the specificity of any antibody detected. Potential study subjects with positive screening for any clinically significant anti-HLA antibody will be excluded and will not be eligible to participate in the NEPHSTROM clinical study (MFI\>1500);
16. History or presence of any medical condition or disease which, in the opinion of the Investigator may place the participant at unacceptable risk for study participation;
17. Childbearing potential without use of effective acceptable methods of contraception. Women of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit (V1) and at baseline visit (V2) if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least two effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate) or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or have had surgical treatment such as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
18. Pregnancy or lactating;
19. Participation in other investigational medicinal product (IMP) trials within 30 days before the inclusion or concurrent to this study (18 month follow-up);
20. Inability to understand the potential risks and benefits of the study;
21. Legal incapacity.
40 Years
85 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Papa Giovanni XXIII Hospital
OTHER
Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Belfast Health and Social Care Trust
OTHER
National University of Ireland, Galway, Ireland
OTHER
University Hospital Birmingham, NHS Foundation Trust, Hospital, Birmingham, UK
UNKNOWN
NHS Blood and Transplant
OTHER_GOV
Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Remuzzi, MD
Role: STUDY_CHAIR
ASST Papa Giovanni XXIII, Bergamo, Italy/IRCCS - Mario Negri Institute for Pharmacological Research
Mattew Griffin, MD
Role: PRINCIPAL_INVESTIGATOR
National University of ireland - Galway University Hospital -Regenerative Medicine Institute
Paul Cockwell, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Birmingham NHS Foundation Trust
Peter Maxwell, MD
Role: PRINCIPAL_INVESTIGATOR
Belfast Health and Social Care Trust - Belfast City Hospital
Locations
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National University of ireland - Galway University Hospital -Regenerative Medicine Institute
Galway, , Ireland
ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò
Bergamo, BG, Italy
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast, , United Kingdom
University Hospital Birmingham NHS Foundation Trust - Queen Elizabeth Medical Centre
Birmingham, , United Kingdom
Countries
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References
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Perico N, Remuzzi G, Griffin MD, Cockwell P, Maxwell AP, Casiraghi F, Rubis N, Peracchi T, Villa A, Todeschini M, Carrara F, Magee BA, Ruggenenti PL, Rota S, Cappelletti L, McInerney V, Griffin TP, Islam MN, Introna M, Pedrini O, Golay J, Finnerty AA, Smythe J, Fibbe WE, Elliman SJ, O'Brien T; NEPHSTROM Trial Consortium. Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM). J Am Soc Nephrol. 2023 Oct 1;34(10):1733-1751. doi: 10.1681/ASN.0000000000000189. Epub 2023 Aug 10.
Lu B, Lerman LO. MSC therapy for diabetic kidney disease and nephrotic syndrome. Nat Rev Nephrol. 2023 Dec;19(12):754-755. doi: 10.1038/s41581-023-00776-z. No abstract available.
Other Identifiers
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2016-000661-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NEPHSTROM
Identifier Type: -
Identifier Source: org_study_id