Chronic Renal Failure of Unknown CausePhase 1/2NCT05154591
CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells
A Phase 1/2 study testing Adipose-derived stromal vascular fraction cells in people with Chronic Renal Failure of Unknown Cause, run by Samuel Vilchez, PhD at 1 site in Nicaragua.
Trial summary
This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Renal Failure of Unknown Cause
- What is being tested?
- Adipose-derived stromal vascular fraction cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNicaragua
- Study dates
- 1 Jan 2018to 28 Feb 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Mesoamerican nephropathy
- Stages 3 and 4
- No other renal disease
- No essential hypertension
Who cannot join
- Significant abnormalities in laboratory tests that contraindicate surgical procedures.
- Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:
- Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb <9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Hospital Escuela Oscar Danilo Rosales Arguello
León
About this study
Official title: Chronic Kidney Disease of Unknown Cause (CKDu) Treated With Directed Local Intra-arterial Infusion of Autologous Stromal Vascular Fraction (SVF) Cells.
This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.
This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.
Read the detailed description
Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).
Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.
Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.
- Conditions
- Chronic Renal Failure of Unknown Cause
- Being tested
- Adipose-derived stromal vascular fraction cells
- Keywords
- Stromal vascular fraction, Mesenchynmal stem cells, Chronic kidney disease, Adipose stem cells
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-derived stromal vascular fraction cellsGenetic
Kidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Treatment | Experimental | Intra-arterial injection of SVF cells into the kidneys. Receives: Genetic: Adipose-derived stromal vascular fraction cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events
Documentation of adverse events
Measured: 36-months follow-up post intervention.
Preliminary evidence of efficacy
Improvement in clinical parameter of GFR as compared with historical age and stage-matched controls.
Measured: Assessment of changes between day 7 and month 36 post intervention.
Secondary outcomes (3)
Renal blood flow.
Distribution of intra-renal blood flow.
Measured: Up to month 12 post intervention.
Kidney volume.
Changes in kidney size (cm3).
Measured: Up to month 12 post intervention.
Renal arterial resistive index.
Decreases in hilar artery resistance index (less o equal to 0.7).
Measured: Up to month 12 post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jan 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal Failure of Unknown CauseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Vilchez, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Salud de Nicaragua, GID BIO, National Autonomous University of Nicaragua
- Responsible party
- Sponsor-investigator, Samuel Vilchez, PhD, National Autonomous University of Nicaragua
- Investigators
- Michael Carstens, MD, Principal investigator, Wake Forrest Institute for Regenerative MedicineDiego Correa, MD, PhD, Principal investigator, University of MiamiSreedhar Mandayam, MD, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154591
- Sponsor's protocol ID
- SVF2015MeN-1
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.
PubMed 28177263Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
PubMed 21726829Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Rios AB, Rivera CM, Calero DW, Zelaya ML, Garcia N, Bertram KA, Rigdon J, Dos-Anjos S, Correa D. Treatment of chronic diabetic foot ulcers with adipose-derived stromal vascular fraction cell injections: Safety and evidence of efficacy at 1 year. Stem Cells Transl Med. 2021 Aug;10(8):1138-1147. doi: 10.1002/sctm.20-0497. Epub 2021 Apr 7.
PubMed 33826245Correa-Rotter R, Garcia-Trabanino R. Mesoamerican Nephropathy. Semin Nephrol. 2019 May;39(3):263-271. doi: 10.1016/j.semnephrol.2019.02.004.
PubMed 31054625Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
PubMed 26546112Johnson RJ, Wesseling C, Newman LS. Chronic Kidney Disease of Unknown Cause in Agricultural Communities. N Engl J Med. 2019 May 9;380(19):1843-1852. doi: 10.1056/NEJMra1813869. No abstract available.
PubMed 31067373Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
PubMed 26565755Wijkstrom J, Gonzalez-Quiroz M, Hernandez M, Trujillo Z, Hultenby K, Ring A, Soderberg M, Aragon A, Elinder CG, Wernerson A. Renal Morphology, Clinical Findings, and Progression Rate in Mesoamerican Nephropathy. Am J Kidney Dis. 2017 May;69(5):626-636. doi: 10.1053/j.ajkd.2016.10.036. Epub 2017 Jan 23.
PubMed 28126239
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Kidney Disease of Unknown Cause (CKDu) Treated With Directed Local Intra-arterial Infusion of Autologous Stromal Vascular Fraction (SVF) Cells.
- ClinicalTrials.gov ID
- NCT05154591
- Acronym / sponsor ID
- SVF2015MeN-1
- Conditions
- Chronic Renal Failure of Unknown Cause
- Keywords
- Stromal vascular fraction, Mesenchynmal stem cells, Chronic kidney disease, Adipose stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Samuel Vilchez, PhDUniversity, hospital or other
- Collaborators
- Ministerio de Salud de Nicaragua, GID BIO, National Autonomous University of Nicaragua
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 13 Dec 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.
This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.
This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.
Detailed description
Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).
Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.
Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral Treatment | Experimental | Genetic: Adipose-derived stromal vascular fraction cellsIntra-arterial injection of SVF cells into the kidneys. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Mesoamerican nephropathy
- Stages 3 and 4
- No other renal disease
- No essential hypertension
Key exclusion criteria (3 listed)
- Significant abnormalities in laboratory tests that contraindicate surgical procedures.
- Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:
- Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb <9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease
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 |
|---|---|---|
| Adipose-derived stromal vascular fraction cellsKidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells. | Genetic | Bilateral Treatment |
Primary outcome
Incidence of treatment related adverse events
Time frame: 36-months follow-up post intervention.
Documentation of adverse events
Preliminary evidence of efficacy
Time frame: Assessment of changes between day 7 and month 36 post intervention.
Improvement in clinical parameter of GFR as compared with historical age and stage-matched controls.
3 secondary outcomes
Renal blood flow.
Time frame: Up to month 12 post intervention.
Kidney volume.
Time frame: Up to month 12 post intervention.
Renal arterial resistive index.
Time frame: Up to month 12 post intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Results publication: PubMed 28177263Brown JC, Shang H, Li Y, Yang N, Patel N, Katz AJ. Isolation of Adipose-Derived Stromal Vascular Fraction Cells Using a Novel Point-of-Care Device: Cell Characterization and Review of the Literature. Tissue Eng Part C Methods. 2017 Mar;23(3):125-135. doi: 10.1089/ten.TEC.2016.0377.
- Results publication: PubMed 21726829Caplan AI, Correa D. The MSC: an injury drugstore. Cell Stem Cell. 2011 Jul 8;9(1):11-5. doi: 10.1016/j.stem.2011.06.008.
- Results publication: PubMed 33826245Carstens MH, Quintana FJ, Calderwood ST, Sevilla JP, Rios AB, Rivera CM, Calero DW, Zelaya ML, Garcia N, Bertram KA, Rigdon J, Dos-Anjos S, Correa D. Treatment of chronic diabetic foot ulcers with adipose-derived stromal vascular fraction cell injections: Safety and evidence of efficacy at 1 year. Stem Cells Transl Med. 2021 Aug;10(8):1138-1147. doi: 10.1002/sctm.20-0497. Epub 2021 Apr 7.
- Results publication: PubMed 31054625Correa-Rotter R, Garcia-Trabanino R. Mesoamerican Nephropathy. Semin Nephrol. 2019 May;39(3):263-271. doi: 10.1016/j.semnephrol.2019.02.004.
- Results publication: PubMed 26546112Guo J, Nguyen A, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 2: Mechanisms of regenerative action. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):180-8. doi: 10.1016/j.bjps.2015.10.014. Epub 2015 Oct 24.
- Results publication: PubMed 31067373Johnson RJ, Wesseling C, Newman LS. Chronic Kidney Disease of Unknown Cause in Agricultural Communities. N Engl J Med. 2019 May 9;380(19):1843-1852. doi: 10.1056/NEJMra1813869. No abstract available.
- Results publication: PubMed 26565755Nguyen A, Guo J, Banyard DA, Fadavi D, Toranto JD, Wirth GA, Paydar KZ, Evans GR, Widgerow AD. Stromal vascular fraction: A regenerative reality? Part 1: Current concepts and review of the literature. J Plast Reconstr Aesthet Surg. 2016 Feb;69(2):170-9. doi: 10.1016/j.bjps.2015.10.015. Epub 2015 Oct 31.
- Results publication: PubMed 28126239Wijkstrom J, Gonzalez-Quiroz M, Hernandez M, Trujillo Z, Hultenby K, Ring A, Soderberg M, Aragon A, Elinder CG, Wernerson A. Renal Morphology, Clinical Findings, and Progression Rate in Mesoamerican Nephropathy. Am J Kidney Dis. 2017 May;69(5):626-636. doi: 10.1053/j.ajkd.2016.10.036. Epub 2017 Jan 23.
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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.
Michael Carstens, MD principal investigator
Wake Forrest Institute for Regenerative Medicine
Diego Correa, MD, PhD principal investigator
University of Miami
Sreedhar Mandayam, MD study director
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1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adipose-derived stromal vascular fraction cells in people with Chronic Renal Failure of Unknown Cause, run by Samuel Vilchez, PhD at 1 site in Nicaragua.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Nov 2023. 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 Nicaragua. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment related adverse events (time frame: 36-months follow-up post intervention.). The study lists 2 primary outcomes in all. 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 NCT05154591, which also lists 8 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 13 Nov 2023.