Type 2 Diabetes MellitusPhase 1/2NCT00703612
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Type 2 Diabetics
A Phase 1/2 study testing Autologous Adipose-derived Stem cells in people with Type 2 Diabetes Mellitus, run by Adistem Ltd at 2 sites in Philippines.
Trial summary
The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Autologous Adipose-derived Stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesPhilippines
- Study dates
- Nov 2007to Jan 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Type II diabetes for at least 2 years
- Type 2 diabetics on oral hypoglycemic agents and/or insulin
- Fasting blood sugar of >200mg% on at least two occasions
- Willing to keep a weekly diary and undergo observation for 12 months
Who cannot join
- Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Beverly Hills Medical Group
Makati City, Manila, 1223
Veterens Memorial Medical Centre
Quezon City, Manila, 1229
About this study
Official title: Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
The purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.
Read the detailed description
Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Autologous Adipose-derived Stem cells
- Keywords
- Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose-derived Stem cellsProcedure or surgery
Intravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This is the only arm and that is the treatment group. Receives: Procedure: Autologous Adipose-derived Stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of blood glucose be it fasting, random or post prandial
Measured: At 2, 4, 12, 24, 36, and 48 weeks
Secondary outcomes (3)
Decrease in anti-hyperglycemic medication dosages.
Measured: At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
Measured: At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
Measured: At 4, 12, 24, 36, and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adistem Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emeritta A Barrenechea, MD, Principal investigator, Veterens Memorial Medical Centre, PhilippinesFlorencio Q Lucero, MD, Principal investigator, University of Philippines, College of Medicine.Letitia Lucero-Palma, MD, Study director, Far Eastern University-NRMF Hospital, Quezon City, PhilippinesBill Paspaliaris, PhD, Study chair, Adistem Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703612
- Sponsor's protocol ID
- Adis-002
- Status last verified
- Jun 2008
- First submitted
- 19 Jun 2008
- Last updated
- 1 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.
PubMed 17495232
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00703612
- Acronym / sponsor ID
- Adis-002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Hyperglycemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Adistem LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 23 Jun 2008 (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 purpose of this study is to determine whether intravenous administration of autologous adipose-derived stem cells is of benefit in the management of types 2 diabetics.
Detailed description
Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase 1/Phase 2 study is to determine whether the intavenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe to and can benefit the disease pathology of patients with Type 2 Diabetes Mellitus (insulin resistance). Patients will be observed over 12 months following the procedure, with a 2 week, 1 month and then tri monthly diagnostics and life style questionaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Autologous Adipose-derived Stem cellsThis is the only arm and that is the treatment group. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of Type II diabetes for at least 2 years
- Type 2 diabetics on oral hypoglycemic agents and/or insulin
- Fasting blood sugar of >200mg% on at least two occasions
- Willing to keep a weekly diary and undergo observation for 12 months
Key exclusion criteria (1 listed)
- Presence of of previous and/or acute diabetic complications such as myocardial infarction, CVA or nephropathy
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 |
|---|---|---|
| Autologous Adipose-derived Stem cellsIntravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue. | Procedure or surgery | Treatment Group |
Primary outcome
Lowering of blood glucose be it fasting, random or post prandial
Time frame: At 2, 4, 12, 24, 36, and 48 weeks
3 secondary outcomes
Decrease in anti-hyperglycemic medication dosages.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Improvement in the general well-being of patients.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
Lowering of glycosylated hemoglobin (HbA1C).
Time frame: At 4, 12, 24, 36, and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2008.
- Background: PubMed 17495232Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.
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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.
Emeritta A Barrenechea, MD principal investigator
Veterens Memorial Medical Centre, Philippines
Florencio Q Lucero, MD principal investigator
University of Philippines, College of Medicine.
Letitia Lucero-Palma, MD study director
Far Eastern University-NRMF Hospital, Quezon City, Philippines
2 sites 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 Autologous Adipose-derived Stem cells in people with Type 2 Diabetes Mellitus, run by Adistem Ltd at 2 sites in Philippines.
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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. 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?
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?
Lowering of blood glucose be it fasting, random or post prandial (time frame: At 2, 4, 12, 24, 36, and 48 weeks). 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 NCT00703612, which also lists 1 linked publication.
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 1 Jul 2008.