Renal FailureNCT01453816
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Renal Failure
A study testing Harvesting and Isolation of Stem cells in people with Renal Failure, run by Ageless Regenerative Institute at 1 site in Mexico.
Trial summary
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Harvesting and Isolation of Stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- May 2011to Jun 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between Age 18 and 80 years.
- Chronic Kidney Disease(CKD) patients of stage III, IV, or V
- Patient should be afebrile 24 hours prior to procedure.
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Who cannot join
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition.
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
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- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. Patients known to have tested positive for Human immunodeficiency virus (HIV), Human T-lymphotropic virus(HTLV), Hepatitis B (HBV),Hepatitis C (HCV), Cytomegalovirus (CMV) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Systolic blood pressure (supine) ≤90 mmHg or greater than 200mmHg
- Resting heart rate > 100 bpm;
- Active clinical infection within one week of enrollment.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Unwilling and/or not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Renal Artery and Intravenously in Patients With Renal Failure
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes
Read the detailed description
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from Renal failure. By injecting ASCs, these regions may become populated with the ASCs, thereby potentially restoring kidney function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
- Conditions
- Renal Failure
- Being tested
- Harvesting and Isolation of Stem cells
- Keywords
- Renal insufficiency, kidney failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting and Isolation of Stem cellsProcedure or surgery
Adipose-Derived Stem Cells (ASCs) will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the renal artery and intravenously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)
Compared to baseline
Measured: 3 months
number of participants with adverse events
Measured: 1 week
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months
Measured: 6 months
number of participants with adverse events
Measured: 2 weeks
number of participants with adverse events
Measured: 4 weeks
Secondary outcomes (2)
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Measured: 3 months
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: No participants and no longer working with off shore center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Responsible party
- Sponsor
- Investigators
- Rigoberto Pallares, MD, Principal investigator, Instituto de Medicina Regenerativa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453816
- Sponsor's protocol ID
- ADI-ME-RF-001
- Status last verified
- Jul 2017
- First submitted
- 3 Oct 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Renal Artery and Intravenously in Patients With Renal Failure
- ClinicalTrials.gov ID
- NCT01453816
- Acronym / sponsor ID
- ADI-ME-RF-001
- Conditions
- Renal Failure
- Keywords
- Renal insufficiency, kidney failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants and no longer working with off shore center
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Study start
- May 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Oct 2011 (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 intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Renal Failure and clinical outcomes
Detailed description
Adipose-Derived Stromal Cells (ASCs) are a novel therapy for patients suffering from Renal failure. By injecting ASCs, these regions may become populated with the ASCs, thereby potentially restoring kidney function. ASCs are a patient-derived ("autologous") cell transplantation technology that is delivered to the patient. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and Females between Age 18 and 80 years.
- Chronic Kidney Disease(CKD) patients of stage III, IV, or V
- Patient should be afebrile 24 hours prior to procedure.
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Key exclusion criteria (16 listed)
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Hemoglobin level below 6g/dl or at the discretion of the physician depending on patient's overall condition.
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
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 |
|---|---|---|
| Harvesting and Isolation of Stem cellsAdipose-Derived Stem Cells (ASCs) will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the renal artery and intravenously. | Procedure or surgery | – |
Primary outcome
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%)
Time frame: 3 months
Compared to baseline
number of participants with adverse events
Time frame: 1 week
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) at 6 months
Time frame: 6 months
number of participants with adverse events
Time frame: 2 weeks
number of participants with adverse events
Time frame: 4 weeks
2 secondary outcomes
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Time frame: 3 months
Improvement in renal biopsy measured by the reduction of scarring etc as compared to baseline
Time frame: 6 months
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 21 Jul 2017.
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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.
Rigoberto Pallares, MD principal investigator
Instituto de Medicina Regenerativa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting and Isolation of Stem cells in people with Renal Failure, run by Ageless Regenerative Institute at 1 site in Mexico.
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 16 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 21 Jul 2017. 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 Mexico. 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.
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?
Significant clinical improvement in serum creatinine and urine output (improvement in measured Glomerular Filtration Rate(GFR) by 50%) (time frame: 3 months). The study lists 5 primary outcomes in all. 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 21 Jul 2017.