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Diabetes Mellitus, Type 1Phase 1/2NCT00260234

Safety and Efficacy of PEG-Encapsulated Islet Allografts Implanted in Type I Diabetic Recipients

A Phase 1/2 study testing Allogeneic Cultured Islet Cells (human); Encapsulated in people with Diabetes Mellitus, Type 1, run by Novocell at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Allogeneic Cultured Islet Cells (human); Encapsulated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
Nov 2005to Dec 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant non-lactating female subjects > 20 years of age
  • Diagnosed with insulin-dependent type I diabetes for at least 20 years
  • BMI less than 28 kg/m2
  • Insulin requirement less than or equal to 0.7 U/kg/day
  • HbA1c greater than or equal to 7.0 %
  • Serum C-peptide concentration less than or equal to 0.5 ng/mL stimulated by an OGTT
  • Female subjects with childbearing potential must have a negative serum pregnancy test prior to enrollment and must agree to use an effective contraceptive method during the study
  • One year of stable diabetes care established in the PI's database without significant changes in insulin requirement or HbA1c or diabetic complication profile

Who cannot join

  • Diagnosis of type II diabetes or maturity onset diabetes of youth (MODY)
  • Serum C-peptide greater than 0.5 ng/mL stimulated by OGTT
  • Sustained hypertension greater than or equal to 100 mmHg diastolic and/or greater than or equal to 160 mmHg systolic
  • History of myocardial infarction or current active cardiac disease
  • Current active infection
  • Significant renal dysfunction as indicated by GFR less than 80 mL/min/1.73 m2 and/or urinary albumin greater than 500 µg/mL
Show all 17Show fewer
  • Significant liver dysfunction as indicated by ALT or AST more than 3X the upper limit of normal
  • Prior whole organ or islet cell transplant
  • Concurrent immunosuppressive therapy
  • Severe gastroparesis, severe peripheral neuropathy, diabetic foot ulcers, or prior amputations due to diabetic complications
  • Any other active autoimmune disease other than autoimmune thyroid disease
  • HIV, HBV or HCV positive status
  • Uncontrolled or untreated proliferative retinopathy
  • Known hypersensitivity or other intolerance to cyclosporine or the inactive ingredients in the product
  • Behavioral activities that place the subject at risk in the opinion of the investigator
  • Any significant concurrent disease, illness, or psychiatric disorder that would, in the opinion of the investigator, compromise subject safety or compliance, or interfere with consent, study participation, follow-up, or the interpretation of study results
  • History of any kind of cancer other than skin cancers (except for melanoma which is exclusionary)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • CHRISTUS Santa Rosa Transplant Institute

    San Antonio, Texas, 78229

  • Diabetes & Glandular Disease Research Associates, P.A.

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Single-Center Phase I/II Study Of Peg-Encapsulated Islet Allografts Implanted In Patients With Type I Diabetes

Insulin dependent Type I diabetics require daily insulin therapy to normalize blood glucose but may have difficulty with significant glycemic excursions and hypoglycemic episodes and crises. Islet cell transplantation can provide relief from daily insulin therapy, normalize blood glucose and reduce or eliminate short and long-term diabetes-related complications. "PEG-Encapsulated Islet Allografts" is a new islet transplant product under development that does not require the ongoing use of immunosuppressive drugs after the implant. This study will test the safety and efficacy of PEG-Encapsulated Islet Allografts in the treatment of Type I diabetes and provide functional outcome measurements.

Read the detailed description

Allogeneic Cultured Islet Cells (human, Novocell); Encapsulated in Polyethylene Glycol; Administered Subcutaneously are a combination biologic and device product in which the pharmacologically active agent is human insulin that is released from the functional islet cells by natural production and release, stimulated by control mechanisms in response to blood glucose concentrations. The device component is a uniform and conformal polymer coating around each islet. Islet cells are isolated from multiple human pancreases procured from human organ donors who meet a specific human donor profile established by the UNOS and the FDA's requirements for Good Tissue Practices. Because the pancreases used for islet cell isolation are not intended for whole-organ transplantation, specific procurement, surgical removal, packaging and shipping protocols are provided by Novocell, Inc. to the Organ Procurement Organizations.

The primary outcome is demonstration that encapsulated islet allografts can be implanted safely in the subcutaneous tissues without the use of long-term immunosuppression. The expected functional outcomes from the implantation of the encapsulated islets are significant reductions in the average blood glucose daily glycemic excursions and in insulin requirements as well as significant increases in C-peptide levels in response to meal challenges. The ultimate expected outcome is that patients who receive these implants will have reduced hemoglobin A1c levels that may be associated with reduced long-term diabetic complications. An important outcome should be reduction in hypoglycemic episodes and crises with significantly functioning grafts without having the risks associated with hepatic portal vein infusion and long-term immunosuppression.

Being tested
Allogeneic Cultured Islet Cells (human); Encapsulated
Keywords
Transplantation, Pancreatic Islets, Diabetes Mellitus, Type 1, Insulin Dependent, Islet Transplant
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Allogeneic Cultured Islet Cells (human); EncapsulatedBiological

Study groups in NCT00260234
Study groupRoleWhat they receive
PEG Islet CellsExperimentalNot described
Receives: Biological: Allogeneic Cultured Islet Cells (human); Encapsulated

What is being measured

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

  1. Safety - will be evaluated by the incidence, grade, and type of adverse events, changes in laboratory parameters, evaluation of the implant site and physical exams.

Secondary outcomes (13)

  1. Efficacy - will be assessed by:

  2. Blood glucose levels

  3. Daily glycemic excursions

  4. Pre-prandial glucose levels

  5. Post-prandial glucose levels

  6. Glucose responses from OGTT (mg/dL and AUC:glucose

  7. Stimulated C-peptide levels from OGTT (ng/mL and

  8. AUC:C-Peptide

  9. HbA1c (%)

  10. Insulin requirements (units/day)

  11. Arginine stimulation tests

  12. Numbers of hypoglycemic and hyperglycemic episodes

  13. Functional duration - will be determined by stimulated C-peptide from OGTT.

Timeline

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

  1. First posted1 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Why it stopped: Stopped in December 2007

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00260234
Sponsor's protocol ID
NC-PCIA-04-001
Other IDs
WIRB #20041068
Status last verified
Sep 2014
First submitted
28 Nov 2005
Last updated
9 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic Cultured Islet Cells (human); Encapsulated in people with Diabetes Mellitus, Type 1, run by Novocell at 2 sites 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: Stopped in December 2007). Results are not available in the source record.

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?

Safety - will be evaluated by the incidence, grade, and type of adverse events, changes in laboratory parameters, evaluation of the implant site and physical exams.. 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 NCT00260234.

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 9 Sep 2014.

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