Graft function after autologous islet transplantation
Analysis of Graft Function Following Autologous Islet Transplantation
We will see if measuring inflammatory markers in blood before and after total pancreatectomy with islet autotransplantation helps explain how well transplanted islet cells work in adults with chronic pancreatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03097185 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll 100 adults with chronic pancreatitis who are scheduled for total pancreatectomy with islet autotransplantation (TP-AIT) or total pancreatectomy (TP) alone at Baylor centers. Blood samples will be collected serially to measure inflammatory markers and blood-based indicators of islet graft function such as C-peptide and glucose control. The cohort includes up to 85 TP-AIT and 15 TP-alone participants and may include patients concurrently enrolled in a reparixin interventional protocol. Data will be analyzed to correlate perioperative inflammation with subsequent islet graft performance.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic pancreatitis who are scheduled for total pancreatectomy with or without islet autotransplantation and who can attend follow-up visits at Baylor are ideal candidates.
Not a fit: Patients who cannot attend required follow-up visits at Baylor or those with very advanced pancreatitis who are not suitable for TP-AIT are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help predict which patients will retain insulin-producing function after TP-AIT and guide personalized perioperative care.
How similar studies have performed: Previous observational work has linked inflammatory markers to islet transplant outcomes, but prospective biomarker profiling specifically around TP-AIT remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with chronic pancreatitis and who are scheduled for TP alone or TP-AIT 2. Patients aged 18 or older 3. Patients are able and willing to attend required follow-up visits at Baylor Exclusion Criteria: 1. Patients who are unable/unwilling to attend follow-up visits at Baylor 2. For TP-AIT subjects: Patients who have advanced stage of chronic pancreatitis. The principal investigator or co-investigators carefully review the medical charts, laboratory results and radiology department reports and determine the suitability for this study.
Where this trial is running
Dallas, Texas
- Baylor University Medical Center - Sammons Outpatient Cancer Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ernest E Beecherl, MD — Sammons Cancer Center, Baylor University Medical Center
- Study coordinator: Anne M Jones, BSN, RN
- Email: anne.jones@bswhealth.org
- Phone: 214-820-7623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.