AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 2TCDNCT01909245

Islet Cell Transplant for Type 1 Diabetes

A Phase 2 study testing Allogenic Human Islet Cells, Immunosuppressive Agents and Gastrin 17 in people with Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Read more about this study

Who is it for?
Ages 18 to 68 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Allogenic Human Islet Cells, Immunosuppressive Agents and Gastrin 17
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
10 Jul 2015to 31 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-68 years
  • Type 1 diabetes mellitus for at least 5 years
  • Ability and willingness to comply with post-transplant regimen, including taking anti-rejection medications, use of reliable contraception, frequent clinic visits, lab tests, careful recording of blood glucose values, insulin doses and medications, and completing detailed follow-up studies
  • Additional Inclusion Criteria nITA Candidates Only
  • Unstable blood sugar control characterized by:
  • Frequent hypoglycemia (blood glucose ≤ 54 mg/dl more than once per week) -AND/OR- Hypoglycemia unawareness (Clarke score of 4 or more) -AND/OR- One or more severe hypoglycemic episodes in 12 months preceding enrollment. -AND/OR- Erratic blood glucose levels that interfere with daily activities -AND/OR- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment
Show all 13Show fewer
  • Additional Inclusion Criteria for RT Candidates Only
  • One or two or previous islet transplants > 1 month prior to screening with continuing insulin requirements and/or HbA1c > 6.5%
  • Additional Inclusion Criteria for IAK Candidates Only
  • Successful kidney transplant > 3 months prior to screening
  • Stable maintenance immunosuppression consisting of tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic or azathoprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic +/- ≤ 10 mg/day corticosteroids
  • No history of acute rejection related to kidney graft in last 12 months and low risk of rejection
  • Under continuing care of physician for kidney graft, who has provided letter in support of candidate's consideration for study participation

Who cannot join

  • Body Mass Index (BMI) > 33
  • Insulin requirements > 1.2 units/kg/day
  • Known sensitization to both rATG -and- alemtuzumab
  • Significant kidney dysfunction
  • Significant liver/gall bladder disease
  • Significant cardiovascular disease
Show all 26Show fewer
  • Active proliferative retinopathy
  • High blood pressure despite appropriate treatment
  • High cholesterol/triglycerides despite appropriate treatment
  • Anemia or other blood disorders that require medical treatment
  • WBC <3,000/ul
  • Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy
  • Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection
  • Epstein-Barr Virus (EBV) IgG negative
  • Any history of malignancy, except for completely resected squamous or basal cell carcinoma of the skin or in situ cancer of the cervix
  • Recent history of non-adherence to medical treatment, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin therapy
  • Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment
  • Previous organ/tissue transplant, except as noted above
  • Administration of live attenuated vaccines within 2 months of enrollment
  • Presence of a chronic disease that must be chronically treated with a contraindicated agent
  • Use of investigational agents within four weeks of enrollment
  • Active alcohol or substance abuse, including cigarette smoking
  • Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures prior to study entry and for as long as they are on immunosuppression medication, and women presently breast feeding are excluded
  • Individuals without health insurance
  • History of gastric bypass
  • Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Islet Transplantation Using a T-Cell Depleting Immunosuppression Induction Regimen

City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump.

Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin.

The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

Being tested
Allogenic Human Islet Cells, Immunosuppressive Agents, Gastrin 17
Keywords
Islet cells, hypoglycemia, hypoglycemia unawareness, islet after kidney transplantation, islet transplant, insulin independence, insulin dependence, labile diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

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

  • Allogenic Human Islet CellsBiological

    Also called Islet transplant, islet transplantation

    Intraportal (into the liver) infusion of islet cells, with a maximum of three islet transplants.

  • Immunosuppressive AgentsDrug

    Anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets.

  • Gastrin 17Drug

    Also called GAST-17

    Gastrin-17 (or GAST-17) - a gut hormone injected under the skin for 30 days (optional treatment for islet dysfunction).

Study groups in NCT01909245
Study groupRoleWhat they receive
Single Arm StudyExperimentalAllogenic Human Islet Cell Transplant with immunosuppression
Receives: Biological: Allogenic Human Islet Cells; Drug: Immunosuppressive Agents; Drug: Gastrin 17

What is being measured

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

  1. Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant

    Measured: 1 year post-transplant

  2. Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant

    Measured: 2 years post-transplant

  3. Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant

    Measured: 5 years post-transplant

Secondary outcomes (1)

  1. Proportion of subjects who are free of severe hypoglycemic episodes AND have a hemoglobin A1c < or = 7.0%

    Measured: +75 days, +6 months, +12 months, and +2, +3, +4 and +5 years post islet transplant

Timeline

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

  1. First posted26 Jul 2013 (estimated)
  2. Study start10 Jul 2015
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909245
Sponsor's protocol ID
12446
Acronym
TCD
Status last verified
Oct 2026
First submitted
22 Jul 2013
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Aslamy A, Oh E, Ahn M, Moin ASM, Chang M, Duncan M, Hacker-Stratton J, El-Shahawy M, Kandeel F, DiMeglio LA, Thurmond DC. Exocytosis Protein DOC2B as a Biomarker of Type 1 Diabetes. J Clin Endocrinol Metab. 2018 May 1;103(5):1966-1976. doi: 10.1210/jc.2017-02492.

    PubMed 29506054

  • Orr C, Stratton J, El-Shahawy M, Forouhar E, Peng A, Singh G, Omori K, Qi M, Kandeel F. Impact of Tacrolimus, Sirolimus, Age, and Body Mass Index on the Occurrence of Skin Cancer and Islet Dysfunction After Transplantation. Cell Transplant. 2025 Jan-Dec;34:9636897241309412. doi: 10.1177/09636897241309412.

    PubMed 39780302

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogenic Human Islet Cells, Immunosuppressive Agents and Gastrin 17 in people with Type 1 Diabetes Mellitus, run by City of Hope Medical Center at 1 site in United States.

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 13 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant (time frame: 1 year post-transplant). The study lists 3 primary outcomes in all. 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 NCT01909245, which also lists 2 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 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in