Type 1 DiabetesNCT01068951

Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells

A study testing Mesenchymal stem cells in people with Type 1 Diabetes, run by Uppsala University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Mesenchymal stem cells
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSweden
Study dates: Jun 2010to Sep 2013
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ability to provide written informed consent
Mentally stable and able to comply with the procedures of the study protocol
Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide >0.1 nmol/l

Who cannot join

Patients with BMI>30
Patients with unstable cardiovascular status
Patients with active infections, unless treatment is not judged necessary by the investigators
Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.
Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.
Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Uppsala University Hospital
Uppsala, SE-75185

Other trials in Sweden

About this study

Official title: Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus

The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.

Conditions: Type 1 Diabetes
Being tested: Mesenchymal stem cells
Keywords: type 1 diabetes, mesenchymal stem cells, intervention
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.

Mesenchymal stem cellsBiological
Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.

Study groups in NCT01068951
Study group	Role	What they receive
Mesenchymal stem cells	Active comparator	Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus. Receives: Biological: Mesenchymal stem cells
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells
Measured: 1 year after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Sep 2013

First posted17 Feb 2010 (estimated)
Study startJun 2010
Primary completionSep 2013
Study completionSep 2013

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 DiabetesStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01068951
Sponsor's protocol ID: AS2010-0180
Status last verified: Feb 2014
First submitted: 16 Feb 2010
Last updated: 5 Feb 2014
Results posted: No

Publications

Carlsson PO, Schwarcz E, Korsgren O, Le Blanc K. Preserved beta-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015 Feb;64(2):587-92. doi: 10.2337/db14-0656. Epub 2014 Sep 9.
PubMed 25204974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01068951
Acronym / sponsor ID: AS2010-0180
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes, mesenchymal stem cells, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Uppsala University HospitalUniversity, hospital or other
Study start: Jun 2010
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 17 Feb 2010 (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 main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mesenchymal stem cells	Active comparator	Biological: Mesenchymal stem cellsComparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus.
Control	No intervention	–

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Ability to provide written informed consent
Mentally stable and able to comply with the procedures of the study protocol
Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide >0.1 nmol/l

Key exclusion criteria (6 listed)

Patients with BMI>30
Patients with unstable cardiovascular status
Patients with active infections, unless treatment is not judged necessary by the investigators
Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.
Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.

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
Mesenchymal stem cellsAutologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.	Biological	Mesenchymal stem cells

Primary outcome

The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells
Time frame: 1 year after intervention

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 5 Feb 2014.
Derived from this study: PubMed 25204974Carlsson PO, Schwarcz E, Korsgren O, Le Blanc K. Preserved beta-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015 Feb;64(2):587-92. doi: 10.2337/db14-0656. Epub 2014 Sep 9.

Related trials for Type 1 Diabetes

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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.

Per-Ola Carlsson, MD, PhD principal investigator

Uppsala University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mesenchymal stem cells in people with Type 1 Diabetes, run by Uppsala University Hospital at 1 site in Sweden.

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 3 inclusion and 6 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 5 Feb 2014. 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 Sweden. 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?

The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells (time frame: 1 year after intervention). 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 NCT01068951, 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 5 Feb 2014.