Type 1 Diabetes MellitusNCT00821899
Bone Marrow Autotransplantation in Type 1 Diabetes
A study testing administration of autologous bone marrow blood in people with Type 1 Diabetes Mellitus, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- administration of autologous bone marrow blood
- How many people
- 3 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2009to May 2010
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diabetes type 1 patients
- 18 to 50 years of age
- more than 5 years of evolution of the disease
- brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes
Who cannot join
- history of cancer
- hematologic alterations
- infectious disease positivity (HIV, HCV etc.)
- diabetic nephropathy
- cardiac failure
- liver disease
- autoimmune systemic disease
- allergy to iodine contrast or anesthesia
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Enric Esmatjes
Barcelona, Barcelona, 08036
Hospital Clinic
Barcelona, Barcelona, 08036
About this study
Official title: Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- administration of autologous bone marrow blood
- Keywords
- diabetes type 1, bone marrow transplantation
- 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.
administration of autologous bone marrow bloodBiological
administration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
Measured: 12 months
Secondary outcomes (3)
Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.
Measured: 12 months
Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.
Measured: 12 months
Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
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.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enric Esmatjes, Hospital Clinic of Barcelona
- Investigators
- Esmatjes Enric, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821899
- Sponsor's protocol ID
- BMATxDM1
- Status last verified
- Mar 2012
- First submitted
- 13 Jan 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Esmatjes E, Montana X, Real MI, Blanco J, Conget I, Casamitjana R, Rovira M, Gomis R, Marin P. Regeneration of insulin production by autologous bone marrow blood autotransplantation in patients with type 1 diabetes. Diabetologia. 2010 Apr;53(4):786-9. doi: 10.1007/s00125-010-1660-9. Epub 2010 Jan 26. No abstract available.
PubMed 20101385
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion
- ClinicalTrials.gov ID
- NCT00821899
- Acronym / sponsor ID
- BMATxDM1
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes type 1, bone marrow transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Jan 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.
This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diabetes type 1 patients
- 18 to 50 years of age
- more than 5 years of evolution of the disease
- brittle diabetes (HbA1c > 8.5 % with intensified treatment or severe hypoglycemia episodes
Key exclusion criteria (8 listed)
- history of cancer
- hematologic alterations
- infectious disease positivity (HIV, HCV etc.)
- diabetic nephropathy
- cardiac 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 |
|---|---|---|
| administration of autologous bone marrow bloodadministration of autologous bone marrow blood through magna pancreatic artery after femoral catheterization once during 12-month study period | Biological | – |
Primary outcome
Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
Time frame: 12 months
3 secondary outcomes
Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.
Time frame: 12 months
Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.
Time frame: 12 months
Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
- Derived from this study: PubMed 20101385Esmatjes E, Montana X, Real MI, Blanco J, Conget I, Casamitjana R, Rovira M, Gomis R, Marin P. Regeneration of insulin production by autologous bone marrow blood autotransplantation in patients with type 1 diabetes. Diabetologia. 2010 Apr;53(4):786-9. doi: 10.1007/s00125-010-1660-9. Epub 2010 Jan 26. No abstract available.
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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.
Esmatjes Enric, MD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of autologous bone marrow blood in people with Type 1 Diabetes Mellitus, run by Hospital Clinic of Barcelona at 2 sites in Spain.
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 8 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: finished, as of the sponsor's last update on 20 Mar 2012. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration. (time frame: 12 months). 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 NCT00821899, 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 20 Mar 2012.