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Type 1 DiabetesPhase 2NCT01350219

Stem Cell Educator Therapy in Type 1 Diabetes

A Phase 2 study testing Stem Cell Educator in people with Type 1 Diabetes, run by Throne Biotechnologies Inc. at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Read more about this study

Who is it for?
Ages 14 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Stem Cell Educator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesin 2 countries
Study dates
Sep 2010to Sep 2019
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 14 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Patients were screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association 2010. Other key inclusion criteria were presence of at least one autoantibody to the pancreatic islet β cells.

Who cannot join

  • Exclusion criteria were any clinically significant diseases in liver, kidney, and heart. Additional exclusion criteria were no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Trial locations and contacts

4 sites in 2 countries.

Yong Zhao, MD, PhD contact

630 723 1968

yzhaowhl@yahoo.com

4 sites in 2 countries

China3 sites, 3 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Xia Li, MD, T1DMCT@gmail.com

    Zhiguang Zhou, MD, PhD

    Recruiting

  • General Hospital of Jinan Military Command

    Jinan, Shandong, 250031

    Zhaoshun Jiang, MD, 86 13953104251

    Zhaoshun Jiang, MD

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

    Huimin Zhou, MD, zhouhuimindoctor@163.com

    Huimin Zhou, MD

    Recruiting

Other trials in China

Spain1 site, 1 recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

    Elias Delgado, MD, 34 985108000, delgadoelias@uniovi.es

    Jesus Otero, MD, 34 985108778, jesus.otero@sespa.princast.es

    Recruiting

Other trials in Spain

About this study

Official title: Phase 2 Study of Stem Cell Educator Therapy in Type 1 Diabetes

The translational potential to the clinical applications of cord blood stem cells has increased enormously in recent years, mainly because of its unique advantages including no risk to the donor, no ethical issues, low risk of graft-versus-host disease (GVHD), rapid availability, and large resource worldwide. Human cord blood contains several types of stem cells such as the umbilical cord blood-derived multipotent stem cells (CB-SC). CB-SC possess multiple biological properties including the expression of embryonic stem (ES) cell characteristics, giving rise to different types of cells and immune modulation. Specifically, CB-SC can function as an immune modulator that can lead to control of the immune responses, which could in turn be used as a new approach to overcome the autoimmunity of Type 1 diabetes (T1D) in patients1 and nonobese diabetic (NOD) mice. Here, the investigators develop a novel Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Educator therapy in T1D patients.

Conditions
Type 1 Diabetes
Being tested
Stem Cell Educator
Keywords
Cord blood stem cells, Immune modulation, Stem cell educator, Autoimmunity, Islet beta cell regeneration, Type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem Cell EducatorDevice

    For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 ~ 9 hrs.

Study groups in NCT01350219
Study groupRoleWhat they receive
Cord blood stem cellExperimentalHuman cord blood-derived multipotent stem cells (CB-SC) display unique phenotypes, such as the expression of embryonic stem (ES) cell markers, multipotential of differentiations, very low immunogenecity, and immune modulations.
Receives: Device: Stem Cell Educator

What is being measured

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

  1. Autoimmune control

    Before treatment, test autoimmune-related markers as baseline; After treatment for 30 days, repeat testing autoimmune-related markers.

    Measured: 30 days post treatment

Secondary outcomes (2)

  1. Metabolic control

    Before treatment, test for C-peptide levels as baseline; After treatment, test C-peptide levels on the 3rd month;

    Measured: 3 months

  2. Analysis of islet beta cell function

    1. Test for C-peptide levels on the 6th month;
    2. Full evaluation of islet beta cell function after one year.

    Measured: 6 months

Timeline

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

  1. First posted9 May 2011 (estimated)
  2. Study startSep 2010
  3. Primary completionSep 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01350219
Sponsor's protocol ID
2010-037
Status last verified
Feb 2019
First submitted
3 May 2011
Last updated
5 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhao Y, Jiang Z, Zhao T, Ye M, Hu C, Yin Z, Li H, Zhang Y, Diao Y, Li Y, Chen Y, Sun X, Fisk MB, Skidgel R, Holterman M, Prabhakar B, Mazzone T. Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med. 2012 Jan 10;10:3. doi: 10.1186/1741-7015-10-3.

    PubMed 22233865

  • Zhao Y, Mazzone T. Human cord blood stem cells and the journey to a cure for type 1 diabetes. Autoimmun Rev. 2010 Dec;10(2):103-7. doi: 10.1016/j.autrev.2010.08.011. Epub 2010 Aug 20.

    PubMed 20728583

  • Zhao Y, Lin B, Darflinger R, Zhang Y, Holterman MJ, Skidgel RA. Human cord blood stem cell-modulated regulatory T lymphocytes reverse the autoimmune-caused type 1 diabetes in nonobese diabetic (NOD) mice. PLoS One. 2009;4(1):e4226. doi: 10.1371/journal.pone.0004226. Epub 2009 Jan 19.

    PubMed 19156219

  • Zhao Y. Stem cell educator therapy and induction of immune balance. Curr Diab Rep. 2012 Oct;12(5):517-23. doi: 10.1007/s11892-012-0308-1.

    PubMed 22833322

  • Delgado E, Perez-Basterrechea M, Suarez-Alvarez B, Zhou H, Revuelta EM, Garcia-Gala JM, Perez S, Alvarez-Viejo M, Menendez E, Lopez-Larrea C, Tang R, Zhu Z, Hu W, Moss T, Guindi E, Otero J, Zhao Y. Modulation of Autoimmune T-Cell Memory by Stem Cell Educator Therapy: Phase 1/2 Clinical Trial. EBioMedicine. 2015 Nov 5;2(12):2024-36. doi: 10.1016/j.ebiom.2015.11.003. eCollection 2015 Dec.

    PubMed 26844283

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stem Cell Educator in people with Type 1 Diabetes, run by Throne Biotechnologies Inc. at 4 sites in 2 countries.

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 1 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong Zhao, MD, PhD (630 723 1968, yzhaowhl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autoimmune control (time frame: 30 days post treatment). 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 NCT01350219, which also lists 5 linked publications.

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 2019.

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