Type 1 Diabetes Trial, Recruiting NCT01999361 Sponsor: Rodolfo Alejandro Condition: Type 1 Diabetes
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Type 1 Diabetes Trial, Recruiting

NCT01999361
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 70 years of age (male or female)
  • People who are able to give written consent to participate
  • People who are mentally stable and able to follow the study procedures
  • People who are currently taking anti-rejection (immunosuppressive) medications, or who are stopping them as part of the standard islet transplant process
  • People who have had at least one islet transplant in the past
  • People whose pancreas produces very little insulin, shown by a specific blood test result (stimulated C-peptide below 0.3 ng/ml) (confirm with trial site)

Who may not be able to join:

  • People with a known history of untreated severe high cholesterol, obesity, or high blood pressure that is difficult to control
  • Women who are pregnant or currently breastfeeding
  • People with an active infection, or a history of hepatitis B, hepatitis C, HIV, or tuberculosis (TB)
  • People with a history of cancer, except for certain types of skin cancer that have been completely removed
  • People with a known active alcohol or substance use problem
  • People with serious heart disease, including a heart attack in the past 6 months, signs of reduced blood flow to the heart found within the last year, or a significantly weakened heart (confirm with trial site)
  • People with a history of persistently abnormal liver test results above a certain level (confirm with trial site)
  • People with a current infection of any kind
  • People with active stomach ulcers
  • People with a history of not following prescribed treatment plans, including anti-rejection medications
  • People whose immune system has developed a high level of sensitivity to donor tissue, based on a specific blood test or the assessment of the study doctor (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Rodolfo Alejandro
Registry
ClinicalTrials.gov
Start date
1 January 2009
Est. completion
1 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

allosensitization after complete islet graft loss

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov