CIT-07: donor-islet transplantation for severe hypoglycemia
What this study tests
A single-arm Phase 3 study in 48 adults with T1D and severe hypoglycemia despite intensive care. At one year, 87.5% reached HbA1c below 7% without severe hypoglycemic events. CIT-07 is a donor-islet study, distinct from the studies supporting Lantidra’s approval.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2019-07-17.
Most recent recorded citation date: 2023-06-28. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults (18-65) who had type 1 diabetes for more than 5 years, made essentially no insulin of their own (no measurable stimulated C-peptide), and kept having severe low-blood-sugar episodes plus reduced ability to feel them coming ("impaired hypoglycemia awareness") despite expert intensive management. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- 87.5% of participants met the primary goal at 1 year (good glucose control with no severe lows), and 71% still met it at 2 years. Median HbA1c fell to 5.6% at both 1 and 2 years, hypoglycemia awareness was restored, and there were no study-related deaths. Bleeding from the procedure (10.4%) and immunosuppression-related infections and reduced kidney function were the main risks.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Achieving HbA1c below 7.0% (53 mmol/mol) at day 365 AND freedom from severe hypoglycemic events from day 28 to day 365 after the first islet transplant
The full picture
Study and results
CIT-07 enrolled 48 adults at eight centers in the United States and Canada. Participants had long-standing T1D, impaired hypoglycemia awareness and severe events despite specialist care. They received donor-islet transplants plus immunosuppression; there was no randomized control group.
The combined endpoint—HbA1c below 7% and no severe hypoglycemia from day 28 to day 365—was reached by 87.5% at one year and 71% at two years. Median HbA1c was 5.6% at both visits. Five participants had bleeding requiring transfusion, two had immunosuppression-related infections, and kidney function declined. No study-related deaths were reported. These benefits and risks concern a selected, high-risk population. Primary report.
Correction: CIT-07 and Lantidra are different study programs
This page previously labeled CIT-07 as Lantidra’s pivotal study. The FDA’s Lantidra approval review instead describes UIH 001 and UIH 002, totaling 30 participants. In that separate program, 21 achieved insulin independence for at least one year and 10 for more than five years. Ninety percent had at least one serious adverse reaction, and two participants died during the studies. Those figures must not be mixed with CIT-07’s 48-person cohort. FDA approval review.
Both programmes use donor islets with immunosuppression, as described in the CIT-07 primary report and the FDA Lantidra approval review. Neither tested a stem-cell-derived product, so neither establishes such a product's efficacy or safety.
Sources
- [1]
- [2]FDA Summary Basis for Regulatory Action: Lantidra · Regulatory decision · 2023-06-28
- [3]NCT00434811: study record · Trial registry — Current status, study design and eligibility checked 16 September 2026; this does not imply posted outcomes.