Type 1 Diabetes MellitusPhase 2NCT00971503
Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes
A Phase 2 study testing autologous bone marrow implantation and Saline injection in people with Type 1 Diabetes Mellitus, run by University of Moron at 1 site in Chile.
Trial summary
Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- autologous bone marrow implantation and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChile
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-30 years of age, diagnosed with diabetes mellitus Type 1 (insulin-dependent).
- Negative antibody titers for GAD and anti-islet.
- Measurements of serum C-peptide below normal values.
- BMI 20-25, men, 19-24, women
Who cannot join
- Diabetes type 2, gestational diabetes, and other types of secondary diabetes.
- Patients with acute metabolic complications of diabetes such as ketoacidosis at least within the last 6 months.
- Abdominal perimeter >102 cm in men; >88cm in women
- Fasting glycemia >100 mg/dl, triglycerides >150 mg/dl, HDL < 40 mg/dl.
- Blood pressure: SBP >135 mmHg and DBP >85 mmHg at the time of randomization
- Patients with BMI > 25 for men and >24 for women.
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- Patients weighing < 40 kg.
- Patients with abnormal ECG indicative of acute or chronic ischemia or acute/chronic necrosis.
- Patients with anemias of any origin.
- Patients undergoing antibiotic treatment for acute infection.
- Patients with any blood abnormality.
- Patients with history of moderate to severe pancreatitis.
- A female subject who is breast-feeding, pregnant, intends to become pregnant or refuses to use a contraceptive method during the course of the study.
- Patients allergic to iodine or filgrastim.
- Patients using medications that could affect this study.
- Patients with serious mental conditions.
- Patients who have undergone a previous stem cell treatment.
- Patients who do not accept and sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Chile1 site
School of Medicine, Pontificia Universidad Catolica de Chile
Santiago, Santiago de Chile
About this study
Official title: Método Para Regenerar el páncreas Con localización in Vivo de médula ósea Total Autologa en Pacientes diabéticos Tipo 1. Estudio Fase IIB.
Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.
Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.
Read more
The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.
This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- autologous bone marrow implantation, Saline injection
- Keywords
- Diabetes type 1, Adult Stem cells, Local injection, Catheter delivery, Bone marrow
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow implantationProcedure or surgery
Filgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery
Saline injectionOther
Injection of saline solution for 5 days
| Study group | Role | What they receive |
|---|---|---|
| saline injection | Sham comparator | Not described Receives: Other: Saline injection |
| Autologous bone marrow implantation | Experimental | Not described Receives: Procedure: autologous bone marrow implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant increase in C-peptide levels after transplant in 70% of the patient.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcomes (2)
Reduction by 50% of the insulin requirement after the transplant in 70% of the patients.
Measured: Two years
Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2012 (estimated)
Why it stopped: Principal Investigator moved to Chile from Argentina
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Moron
- Sponsor type
- University, hospital or other
- Investigators
- Alejandro D. Mesples, MD, Principal investigator, University of Morón, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971503
- Sponsor's protocol ID
- CM 02
- Status last verified
- Jul 2011
- First submitted
- 1 Sep 2009
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Método Para Regenerar el páncreas Con localización in Vivo de médula ósea Total Autologa en Pacientes diabéticos Tipo 1. Estudio Fase IIB.
- ClinicalTrials.gov ID
- NCT00971503
- Acronym / sponsor ID
- CM 02
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes type 1, Adult Stem cells, Local injection, Catheter delivery, Bone marrow
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator moved to Chile from Argentina
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of MoronUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 3 Sep 2009 (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.
Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.
Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.
The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.
This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline injection | Sham comparator | Other: Saline injection |
| Autologous bone marrow implantation | Experimental | Procedure: autologous bone marrow implantation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18-30 years of age, diagnosed with diabetes mellitus Type 1 (insulin-dependent).
- Negative antibody titers for GAD and anti-islet.
- Measurements of serum C-peptide below normal values.
- BMI 20-25, men, 19-24, women
Key exclusion criteria (18 listed)
- Diabetes type 2, gestational diabetes, and other types of secondary diabetes.
- Patients with acute metabolic complications of diabetes such as ketoacidosis at least within the last 6 months.
- Abdominal perimeter >102 cm in men; >88cm in women
- Fasting glycemia >100 mg/dl, triglycerides >150 mg/dl, HDL < 40 mg/dl.
- Blood pressure: SBP >135 mmHg and DBP >85 mmHg at the time of randomization
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 bone marrow implantationFilgrastim treatment before bone marrow aspiration that will then be implanted via pancreatic artery | Procedure or surgery | Autologous bone marrow implantation |
| Saline injectionInjection of saline solution for 5 days | Other | saline injection |
Primary outcome
Significant increase in C-peptide levels after transplant in 70% of the patient.
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months
2 secondary outcomes
Reduction by 50% of the insulin requirement after the transplant in 70% of the patients.
Time frame: Two years
Normalization of the hemoglobin A1C after transplant in 70% of the patients. Normalization of blood glucose levels.
Time frame: one year
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 27 Jul 2011.
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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.
Alejandro D. Mesples, MD principal investigator
University of Morón, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous bone marrow implantation and Saline injection in people with Type 1 Diabetes Mellitus, run by University of Moron at 1 site in Chile.
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 18 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 27 Jul 2011. 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 Chile. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 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 increase in C-peptide levels after transplant in 70% of the patient. (time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months). 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 27 Jul 2011.