Diabetic Kidney DiseasePhase 1/2NEPHSTROMNCT02585622
NEPHSTROM for Diabetic Kidney Disease
A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Diabetic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 4 sites in 3 countries.
Trial summary
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 Dec 2017to 3 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female ≥ 40 years and <85 years old. ;
- 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.
Who cannot join
- Current resting systolic BP ≥ 150 mmHg and current resting diastolic BP ≥ 90 mmHg in a clinical setting, despite treatment with 3 hypertensive agents of different classes (including one diuretic), measured in a quiet environment with morning medications already taken;
- Initiation of a new anti-hypertensive agent within the past 6 months
- Increase the dose of an anti-hypertensive agent by ≥ 100% of the previous dose within the past 3 months
- Current HbA1c > 75 mmol/mol (> 9%)
- Initiation of a new hypoglycaemic agent within the past 6 months
- Increase the dose of a hypoglycaemic agent by ≥ 100% of the previous dose within the past 3 months
Show all 22Show fewer
- Current fasting total cholesterol > 7 mmol/l
- Current fasting total triglycerides > 3.5 mmol/l
- Initiation of a new lipid lowering agent within the past 6 months
- Other exclusion criteria:
- Chronic lung or liver disease;
- Cardiovascular events (myocardial infarction, stroke or acute limb ischemia) within 6 months prior to enrolment;
- Current or history within 6 months prior to enrolment of NYHA class III or IV heart failure;
- 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;
- Irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
- 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);
- 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;
- 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.
- Pregnancy or lactating;
- Participation in other investigational medicinal product (IMP) trials within 30 days before the inclusion or concurrent to this study (18 month follow-up);
- Inability to understand the potential risks and benefits of the study;
- Legal incapacity.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Belfast Health and Social Care Trust - Belfast City Hospital
Belfast
University Hospital Birmingham NHS Foundation Trust - Queen Elizabeth Medical Centre
Birmingham
Ireland1 site
National University of ireland - Galway University Hospital -Regenerative Medicine Institute
Galway
Italy1 site
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, 24027
About this study
Official title: Novel Stromal Cell Therapy for Diabetic Kidney Disease (NEPHSTROM Study)
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD).
- Conditions
- Diabetic Kidney Disease
- Being tested
- Mesenchymal Stromal Cells, Placebo
- Keywords
- Diabetic Kidney Disease, Mesenchymal Stromal Cells (MSC), immune response, allogeneic, disease progression
- Medical subject headings
- Diabetic Nephropathies, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal CellsBiological
Also called Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M)
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
PlaceboOther
Also called Cryostor CS10
Volume total of fluid infused: 40 ml
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow-derived Mesenchymal Stromal Cells | Experimental | Not described Receives: Biological: Mesenchymal Stromal Cells |
| Cryostor CS10 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of all pre-specified infusion-associated events and the overall number and frequency of adverse events.
At each visit overall clinical condition of the patient will be evaluated and any adverse event wil be recorded.
Measured: Changes from baseline to study completion, up to 18 months after cell or placebo infusion.
Secondary outcomes (18)
Glomerular filtration rate (GFR)
GFR will be measured by plasma clearance of unlabelled exogenous marker Iohexol and estimated by CKD-EPI and MDRD equations.
Measured: Changes from baseline up to 18 months after cell or placebo infusion.
Urinary Albumin/Creatinine Ratio (ACR)
ACR will be measured on spot morning urine samples.
Measured: Changes from baseline at 6 months and then every six months to study completion,up to 18 months after cell or placebo infusion.
Urinary albumin excretion (UAE).
UAE will be measured on 24h urine samples using standardized methods.
Measured: Changes from baseline at 6 months and then every six months to study completion,up to 18 months after cell or placebo infusion.
Fasting blood glucose (target <126mg/dL)
Measured: Proportion of study participants within target range (<126mg/dL) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
HbA1c (target <75mmol/mol or <9%)
Measured: Proportion of study participants within target range (<75mmol/mol or <9%) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Total cholesterol (target <200 mg/dl)
Measured: Proportion of study participants within target range (<200 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
LDL cholesterol (target <100 mg/dl)
Measured: Proportion of study participants within target range (<100 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Triglycerides (target <170 mg/dl)
Measured: Proportion of study participants within target range (<170 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Arterial blood pressure (the target value <130/80 mmHg)
Measured: Proportion of study participants within target range (<130/80 mmHg)at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Quality of life
Quality of life will be evaluated by the administration of SF36 questionnaire.
Measured: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Quality of life
Quality of life will be evaluated by the administration of EQ-5D-5L questionnaire.
Measured: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Anti-HLA antibody development
Measured: Changes from baseline to 3,12 and 18 months after cell or placebo infusion.
Inflammation and fibrosis related soluble mediators
Blood and urine bio-chip-based multiplex assay
Measured: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Serum/plasma concentrations (pg/ml) of biomarkers of inflammation.
Biomarkers will include sTNFR1, sTNFR2, Il-6,TNF-alfa, IL-1beta, MCP-1 (CCL2), IL-8, FGF21.
Measured: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Serum/plasma concentrations (ng/ml) of biomarkers of CKD progression.
Biomarkers will include Cystatin C, NGAL, Adiponectin, Leptin.
Measured: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Urine concentrations (pg/ml adjusted to urine creatinine concentration) of biomarkers of inflammation.
Biomarkers will include sTNFR1, sTNFR2, Il-6,TNF-alfa, IL-1beta, MCP-1 (CCL2), IL-8.
Measured: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Proportion/total number of circulating T cells, B cells, NK cells, monocytes, dendritic cells
Measured: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Cost-effectiveness of cell therapy
Cost-effectiveness of cell therapy will be evaluated by providing the patients with a healthcare resource diary.
Measured: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start11 Dec 2017
- Primary completion3 Nov 2022
- Study completion3 Jan 2024
Why it stopped: IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Papa Giovanni XXIII Hospital, Istituto Di Ricerche Farmacologiche Mario Negri, Belfast Health and Social Care Trust, National University of Ireland, Galway, Ireland, University Hospital Birmingham NHS Foundation Trust, NHS Blood and Transplant
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, MD, Study chair, ASST Papa Giovanni XXIII, Bergamo, Italy/IRCCS - Mario Negri Institute for Pharmacological ResearchMattew Griffin, MD, Principal investigator, National University of ireland - Galway University Hospital -Regenerative Medicine InstitutePaul Cockwell, MD, Principal investigator, University Hospital Birmingham NHS Foundation TrustPeter Maxwell, MD, Principal investigator, Belfast Health and Social Care Trust - Belfast City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585622
- Sponsor's protocol ID
- NEPHSTROM
- Other IDs
- 2016-000661-23, 2016
- Acronym
- NEPHSTROM
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2015
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37560967Lu 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.
PubMed 37783947
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Stromal Cell Therapy for Diabetic Kidney Disease (NEPHSTROM Study)
- ClinicalTrials.gov ID
- NCT02585622
- Acronym / sponsor ID
- NEPHSTROM / NEPHSTROM
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic Kidney Disease, Mesenchymal Stromal Cells (MSC), immune response, allogeneic, disease progression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Papa Giovanni XXIII Hospital, Istituto Di Ricerche Farmacologiche Mario Negri, Belfast Health and Social Care Trust, National University of Ireland, Galway, Ireland, University Hospital Birmingham NHS Foundation Trust, NHS Blood and Transplant
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow-derived Mesenchymal Stromal Cells | Experimental | Biological: Mesenchymal Stromal Cells |
| Cryostor CS10 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female ≥ 40 years and <85 years old. ;
- 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;
Key exclusion criteria (22 listed)
- Current resting systolic BP ≥ 150 mmHg and current resting diastolic BP ≥ 90 mmHg in a clinical setting, despite treatment with 3 hypertensive agents of different classes (including one diuretic), measured in a quiet environment with morning medications already taken;
- Initiation of a new anti-hypertensive agent within the past 6 months
- Increase the dose of an anti-hypertensive agent by ≥ 100% of the previous dose within the past 3 months
- Current HbA1c > 75 mmol/mol (> 9%)
- Initiation of a new hypoglycaemic agent within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stromal CellsAlso: Allogeneic Cellular Therapy (NEPHSTROM ORBCEL-M)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 | Biological | Bone marrow-derived Mesenchymal Stromal Cells |
| PlaceboAlso: Cryostor CS10Volume total of fluid infused: 40 ml | Other | Cryostor CS10 |
Primary outcome
Number and severity of all pre-specified infusion-associated events and the overall number and frequency of adverse events.
Time frame: Changes from baseline to study completion, up to 18 months after cell or placebo infusion.
At each visit overall clinical condition of the patient will be evaluated and any adverse event wil be recorded.
18 secondary outcomes
Glomerular filtration rate (GFR)
Time frame: Changes from baseline up to 18 months after cell or placebo infusion.
Urinary Albumin/Creatinine Ratio (ACR)
Time frame: Changes from baseline at 6 months and then every six months to study completion,up to 18 months after cell or placebo infusion.
Urinary albumin excretion (UAE).
Time frame: Changes from baseline at 6 months and then every six months to study completion,up to 18 months after cell or placebo infusion.
Fasting blood glucose (target <126mg/dL)
Time frame: Proportion of study participants within target range (<126mg/dL) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
HbA1c (target <75mmol/mol or <9%)
Time frame: Proportion of study participants within target range (<75mmol/mol or <9%) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Total cholesterol (target <200 mg/dl)
Time frame: Proportion of study participants within target range (<200 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
LDL cholesterol (target <100 mg/dl)
Time frame: Proportion of study participants within target range (<100 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Triglycerides (target <170 mg/dl)
Time frame: Proportion of study participants within target range (<170 mg/dl) at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Arterial blood pressure (the target value <130/80 mmHg)
Time frame: Proportion of study participants within target range (<130/80 mmHg)at baseline and at each time point (day 1, day 7, month 1,3,6,12,18 after cell or placebo infusion).
Quality of life
Time frame: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Quality of life
Time frame: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Anti-HLA antibody development
Time frame: Changes from baseline to 3,12 and 18 months after cell or placebo infusion.
Inflammation and fibrosis related soluble mediators
Time frame: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Serum/plasma concentrations (pg/ml) of biomarkers of inflammation.
Time frame: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Serum/plasma concentrations (ng/ml) of biomarkers of CKD progression.
Time frame: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Urine concentrations (pg/ml adjusted to urine creatinine concentration) of biomarkers of inflammation.
Time frame: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Proportion/total number of circulating T cells, B cells, NK cells, monocytes, dendritic cells
Time frame: Changes from baseline to 7 days, 1,6,12 and 18 months after cell or placebo infusion.
Cost-effectiveness of cell therapy
Time frame: Changes from baseline to 1,3,6,12 and 18 months after cell or placebo infusion.
Results and safety
The study was stopped early (reason given: IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Results publication: PubMed 37560967Perico 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.
- Derived from this study: PubMed 37783947Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Remuzzi, MD study chair
ASST Papa Giovanni XXIII, Bergamo, Italy/IRCCS - Mario Negri Institute for Pharmacological Research
Mattew Griffin, MD principal investigator
National University of ireland - Galway University Hospital -Regenerative Medicine Institute
Paul Cockwell, MD principal investigator
University Hospital Birmingham NHS Foundation Trust
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stromal Cells in people with Diabetic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Ireland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IMP NEPHSTROM ORBECEL-M is expired and additional extension is not feasible. Low recruitment rate at Birmingham center.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of all pre-specified infusion-associated events and the overall number and frequency of adverse events. (time frame: Changes from baseline to study completion, up to 18 months after cell or placebo infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585622, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.