Kidney DiseasesPhase 1NCT04896567
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
A Phase 1 study testing Cell isolation in people with Kidney Diseases and Endothelial Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Diseases, Endothelial Dysfunction
- What is being tested?
- Cell isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 30 Dec 2024
- Phase
- Phase 1
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients who have a clinical indication for kidney biopsy will be considered.
- All subjects will be at least 18 years of age and may be of any gender.
- Patients undergoing a native or kidney transplant biopsy will be considered.
Who cannot join
- Patients not undergoing a kidney biopsy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.
Read the detailed description
Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.
- Conditions
- Kidney Diseases, Endothelial Dysfunction
- Being tested
- Cell isolation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell isolationDiagnostic test
Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will have kidney biopsy designated for cell isolation and culture. Receives: Diagnostic Test: Cell isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell growth
Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.
Measured: 1 week
Secondary outcomes (1)
Kidney disease progression
Isolated cell growth will be compared to serum creatinine of patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start21 Jan 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Superseded by a separate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive patients will be consented to obtain kidney biopsy material.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Michael Siedlecki, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896567
- Sponsor's protocol ID
- awaiting IRB approval
- Status last verified
- Jul 2022
- First submitted
- 31 Aug 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
- ClinicalTrials.gov ID
- NCT04896567
- Acronym / sponsor ID
- awaiting IRB approval
- Conditions
- Kidney Diseases, Endothelial Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Superseded by a separate study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 21 Jan 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 May 2021 (actual)
- 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.
Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.
Detailed description
Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive patients will be consented to obtain kidney biopsy material.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Cell isolationPatients will have kidney biopsy designated for cell isolation and culture. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Only patients who have a clinical indication for kidney biopsy will be considered.
- All subjects will be at least 18 years of age and may be of any gender.
- Patients undergoing a native or kidney transplant biopsy will be considered.
Key exclusion criteria (1 listed)
- Patients not undergoing a kidney biopsy will be excluded.
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 |
|---|---|---|
| Cell isolationTissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells. | Diagnostic test | Intervention |
Primary outcome
Cell growth
Time frame: 1 week
Tissue will be isolated and cell viability will be documented by rate of colony growth over one week per patient enrolled.
1 secondary outcome
Kidney disease progression
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cell isolation in people with Kidney Diseases and Endothelial Dysfunction, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 withdrawn before enrolling participants, so there are no results.
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?
Cell growth (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.