Diabetes Mellitus Type IINCT01453751
Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered in Patients With Type II Diabetes
A study testing Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF) in people with Diabetes Mellitus Type II, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type II
- What is being tested?
- Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2017
- 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.
- Type 2 diabetes mellitus (as guideline WHO, 1999);
- Body mass index (BMI)≤35㎏/㎡;
- Fast blood glucose (FBG)≥7.0 mmol/L, and Hemoglobin A1c (HgbA1c)≥7％;
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Who cannot join
- 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.
- 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. If patients have tested positive, they will be consulted 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
Show all 12Show fewer
- Systolic blood pressure (supine) ≤90 mmHg or >180mmHg
- 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.
United States1 site
Ageless Regenerative Institute LLC
Aventura, Florida, 33180
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 Intravenously in Patients With Type II Diabetes
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.
- Conditions
- Diabetes Mellitus Type II
- Being tested
- Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)
- Keywords
- Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)Procedure or surgery
Also called Lipoaspiration, Liposuction
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Injection of AD-SVF | Experimental | Intravenous administration of AD-SVF. Receives: Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of insulin requirement by > 50%
Measured: 3 months and 6 months
Number of adverse events reported
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Measured: up to the 6-month period following treatment
Secondary outcomes (2)
Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
Blood sample
Measured: 3 months and 6 months
reduction in requirement of insulin dosage compared to baseline
Measured: 3 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 startMar 2014
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: company dissolved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies 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
- Not applicable
- 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)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453751
- Sponsor's protocol ID
- AD-US-DM2-001
- Status last verified
- Nov 2017
- First submitted
- 3 Oct 2011
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 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 Intravenously in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT01453751
- Acronym / sponsor ID
- AD-US-DM2-001
- Conditions
- Diabetes Mellitus Type II
- Keywords
- Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company dissolved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (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.
This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal vascular fraction cells implantation via intravenous infusion.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Type II Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous Injection of AD-SVF | Experimental | Procedure: Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)Intravenous administration of AD-SVF. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and Females between Age 18 and 80 years.
- Type 2 diabetes mellitus (as guideline WHO, 1999);
- Body mass index (BMI)≤35㎏/㎡;
- Fast blood glucose (FBG)≥7.0 mmol/L, and Hemoglobin A1c (HgbA1c)≥7％;
- Up to date on all age and gender appropriate cancer screening per American Cancer Society.
Key exclusion criteria (12 listed)
- 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.
- 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. If patients have tested positive, they will be consulted 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
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 Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)Also: Lipoaspiration, LiposuctionASCs 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. | Procedure or surgery | Intravenous Injection of AD-SVF |
Primary outcome
Reduction of insulin requirement by > 50%
Time frame: 3 months and 6 months
Number of adverse events reported
Time frame: up to the 6-month period following treatment
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
2 secondary outcomes
Improvement of Hemoglobin A1c(HbA1c) levels as compared to baseline
Time frame: 3 months and 6 months
reduction in requirement of insulin dosage compared to baseline
Time frame: 3 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 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus Type II
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
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 Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF) in people with Diabetes Mellitus Type II, run by Ageless Regenerative Institute 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 5 inclusion and 12 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 24 Nov 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 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.
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?
Reduction of insulin requirement by > 50% (time frame: 3 months and 6 months). 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?
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 24 Nov 2017.