NCT00315627 is a Phase 2 clinical trial of Islet transplantation in Type 1 Diabetes Mellitus, sponsored by Rodolfo Alejandro.

Who is sponsoring NCT00315627?

NCT00315627 is sponsored by Rodolfo Alejandro.

What drugs are being tested in NCT00315627?

Interventions in NCT00315627: Islet transplantation.

What condition does NCT00315627 study?

NCT00315627 studies Type 1 Diabetes Mellitus.

Is NCT00315627 still recruiting?

NCT00315627 is currently completed. Last updated 18 April 2017.

Are results published for NCT00315627?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-18 · How we verify

NCT00315627

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Steroid-free and Long-term Calcineurin-free Trial in Islet Cell Transplantation

Completed Phase 2 Results posted Last updated 18 April 2017

What this trial tests

Phase 2 trial testing Islet transplantation in Type 1 Diabetes Mellitus in 3 participants. Completed in 1 January 2014.

Timeline

1 July 2005

Primary endpoint
1 January 2014

1 January 2014

Quick facts

Lead sponsor	Rodolfo Alejandro
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 July 2005
Primary completion	1 January 2014
Estimated completion	1 January 2014
Sites	1 location across United States

Drugs / interventions tested

Islet transplantation — full drug profile →

Conditions studied

Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Rodolfo Alejandro — full company profile →

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia
Time frame: 1 year
Number of subjects at 1 year with HbA1c \< 6.5% and absence of severe hypoglycemia

Sponsor's own description

The purposes of this study are: 1. To reverse hyperglycemia and insulin dependency in patients with type 1 diabetes mellitus through islet transplantation utilizing steroid free, calcineurin-inhibitor free immunosuppression. 2. To assess the long-term function of successful islet transplants in patients with type 1 diabetes mellitus utilizing islets that have undergone a period of culture. 3. To determine whether the natural history of the microvascular, macrovascular, and neuropathic complications are altered following the successful transplantation of islets.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Islet cell transplant: Update on current clinical trials.
Schuetz C, Markmann JF. · · 2016 · cited 13× · PMID 28451515 · DOI 10.1007/s40472-016-0103-z
HLA-B Matching Prolongs Allograft Survival in Islet Cell Transplantation.
Lemos JRN, Baidal DA, Poggioli R, Fuenmayor V, et al · · 2023 · cited 7× · PMID 37526141 · DOI 10.1177/09636897231166529
G-CSF and Exenatide Might Be Associated with Increased Long-Term Survival of Allogeneic Pancreatic Islet Grafts.
Zoso A, Serafini P, Lanzoni G, Peixoto E, et al · · 2016 · cited 7× · PMID 27285580 · DOI 10.1371/journal.pone.0157245
Impact of GAD65 and IA2 autoantibodies on islet allograft survival.
Lemos JRN, Poggioli R, Ambut J, Bozkurt NC, et al · · 2023 · cited 3× · PMID 38028981 · DOI 10.3389/fcdhc.2023.1269758

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Rodolfo Alejandro trials

Trials by the same sponsor.

NCT03406897 — Pilot Study of OMEGA-3 and Vitamin D in High-Dose in Type I Diabetic Patients · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00315627 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rodolfo Alejandro
Last refreshed: 18 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00315627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing