Type 1 Diabetes MellitusPhase 1/2NCT00703599
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes
A Phase 1/2 study testing Autologous Adipose-derived Stem cells in people with Type 1 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 stem cells is safe and beneficial in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Type 1 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
- 30 participants
- Where
- 2 sitesPhilippines
- Study dates
- Nov 2007to Dec 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of Type I diabetes for at least 2 years
- Insulin-dependent
Who cannot join
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites, 2 recruiting
- Recruiting
Beverly Hills Medical Group
Makati City, Manila
Florencio Q Lucero, MD, 63-917-896-6411, dr-flucero@pldtdsl.net
Florencio Q Lucero, MD
- Recruiting
Veterens Memorial Medical Centre
Quezon City, Manila, 1229
Emerita A Barrenechea, MD, 63-917-811-1008, emieab@yahoo.com
Emerita A Barrenechea, MD
About this study
Official title: Phase I/II Study of Intravenous Administration of Activated Autologous Adipose-Derived Stromal Vascular Fraction in Patients With Type 1 Diabetes
The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.
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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Autologous Adipose-derived Stem cells
- Keywords
- Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Insulin-dependence
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
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
Also called Treatment Group
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 |
|---|---|---|
| 1 | 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 insulin-dependence and anti-hyperglycemic medication dosages
Measured: At 2, 4, 12, 24, 36, and 48 weeks
Secondary outcomes (4)
Lowering of glycosylated hemoglobin (HbA1C).
Measured: At 4, 12, 24, 36, and 48 weeks
Increased circulating C-Peptide levels
Measured: At 4, 12, 24, 36, and 48 weeks.
Increased general well-being of patients.
Measured: At 2, 4, 12, 24, 36, and 48 weeks.
No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.
Measured: At 2, 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 completionNov 2009 (estimated)
- Study completionDec 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 1 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
- 30 participants (estimated)
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 MedicineLetitia Lucero-Palma, MD, Study director, Far Eastern University-NRMF Hospital, Quezon City, PhilippinesBill Paspaliaris, PhD, Study chair, Adistem Ltd, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703599
- Sponsor's protocol ID
- Ad-003
- 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 1 Diabetes
- ClinicalTrials.gov ID
- NCT00703599
- Acronym / sponsor ID
- Ad-003
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Adipose-derived stem cells, Adipose stromal vascular fraction, Autologous, Insulin-dependence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Adistem LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 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 stem cells is safe and beneficial in patients with type 1 diabetes.
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 I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and 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 |
|---|---|---|
| 1 | Experimental | Procedure: Autologous Adipose-derived Stem cellsThis is the only arm and that is the treatment group. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of Type I diabetes for at least 2 years
- Insulin-dependent
Key exclusion criteria (1 listed)
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
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 cellsAlso: Treatment GroupIntravenous administration of autologous activated stromal vascular fraction derived from 100-120 ml lipoaspirate following mini-liposuction of abdominal adipose tissue. | Procedure or surgery | 1 |
Primary outcome
Lowering of insulin-dependence and anti-hyperglycemic medication dosages
Time frame: At 2, 4, 12, 24, 36, and 48 weeks
4 secondary outcomes
Lowering of glycosylated hemoglobin (HbA1C).
Time frame: At 4, 12, 24, 36, and 48 weeks
Increased circulating C-Peptide levels
Time frame: At 4, 12, 24, 36, and 48 weeks.
Increased general well-being of patients.
Time frame: At 2, 4, 12, 24, 36, and 48 weeks.
No detrimental change seen in kidney function tests, liver function tests and other haematological parameters.
Time frame: At 2, 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.
Related trials for Type 1 Diabetes Mellitus
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
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 1 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 2 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?
Contact Letitia Lucero-Palma, MD (63-916-478-7512, lettielucero@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowering of insulin-dependence and anti-hyperglycemic medication dosages (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 NCT00703599, 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.