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Diabetes Mellitus, Type 1Phase 1NCT00303134

Islet Cell Transplants for Diabetes

A Phase 1 study testing Islet Cell Transplantation in people with Diabetes Mellitus, Type 1, run by Weill Medical College of Cornell University at 1 site 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

The purpose of this study is to test the safety and efficacy of islet cell transplants for the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood sugar levels can prevent progression of complications (such as kidney disease, nerve damage, and vascular disease) from diabetes. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Islet Cell Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
1 Aug 2003to 24 Jun 2010
Phase
Phase 1
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrolling subjects must have Type 1 diabetes mellitus for more than 5 years, complicated by at least one of the following situations that persist despite intensive insulin management efforts. (Intensive management is defined as monitoring of glucose values at home no less than three times each day and by the administration of three or more insulin injections each day. Such management must be monitored in close cooperation with an endocrinologist or primary care physician, as defined by at least three contacts during the previous 12 months. If an endocrinologist did not participate in the ongoing management effort during the past year, then an independent endocrinologist must assess the adequacy of the management efforts prior to enrollment.) The complicating situations are:
  • Reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels of < 54 mg/dL, b. Metabolic lability/instability, characterized by two or more episodes of severe hypoglycemia and which is associated with a blood glucose below 54 mg/dl OR two or more hospital visits for diabetic ketoacidosis over the last year, c. Despite efforts at optimal glucose control, progressive secondary complications of diabetes as defined by: i) Retinopathy-a minimum of a three step progression using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system 44,or an equivalent progression as certified by an ophthalmologist familiar with diabetic retinopathy, or ii) Nephropathy-a confirmed rise of 50 µg/min (72 mg/24h) of microalbuminuria or greater over at least three months (beginning anytime within the past two years) despite the use of an ACE inhibitor, or iii) Neuropathy-persistent or progressing autonomic neuropathy (gastroparesis, postural hypotension, neuropathic bowel or bladder) or persistent or progressing severe peripheral painful neuropathy not responding to usual management (e.g., tricyclics, gabapentin, or carbamazepine).

Who cannot join

  • Severe co-existing cardiac disease, characterized by any one of these conditions:
  • Recent myocardial infarction (within past six months), or
  • Angiographic evidence of non-correctable coronary artery disease, or
  • Evidence of ischemia on functional cardiac exam (functional testing is required for all subjects, with a stress echo test recommended for subjects with a history of ischemic disease). Patients unable to perform an exercise stress echocardiogram test will undergo adenosine vasodilator stress test, and if there is a history of bronchospasm, will undergo dobutamine stress test.
  • Active alcohol or substance abuse-includes cigarette smoking (must be abstinent for six months). Active alcohol abuse should be considered using the current NIAAA definitions, whereby alcohol abuse is defined by a pattern of drinking that is accompanied by one or more of the following situations within a 12-month period:
  • Failure to fulfill major work, school, or home responsibilities;
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  • Drinking in situations that are physically dangerous, such as while driving a car or operating machinery;
  • Recurring alcohol-related legal problems, such as being arrested for driving under the influence of alcohol or for physically hurting someone while drunk;
  • Continued drinking despite having ongoing relationship problems that are caused or worsened by the effects of alcohol.
  • Psychiatric disorder making the subject not a suitable candidate for transplantation, e.g., schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medication. (A psychological or psychiatric consultation is required only if considered necessary by some current indication or history.)
  • History of non-adherence to prescribed regimens
  • Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)
  • Any history of or current malignancies except squamous or basal skin cancer
  • BMI > 26 kg/m2
  • C-peptide response to arginine stimulation (5 gm I.V.) (any C-peptide ≥ 0.3 ng/mL at 2, 3, 4, 5, 7 and 10 min post-infusion)
  • Inability to provide informed consent
  • Age less than 18 or greater than 65 years
  • Creatinine clearance <80 mL/min/1.73 m2
  • Serum creatinine >1.6 mg/dL
  • Macroalbuminuria (urinary albumin excretion rate >300 mg/24h)
  • Baseline Hb <10.5 gm/dL in women, or <13 gm/dL in men
  • Baseline LFT's outside of normal range with the exception of Gilberts Syndrome. (An initial LFT test panel with any values >1.5 times upper limits of normal will exclude a patient; a re-test for any values between normal and 1.5 times normal should be made, and if the values remain elevated above normal limits, the patient will be excluded.)
  • Presence of gallstones (subjects may be eligible two weeks after a laparoscopic cholecystectomy)
  • Portal hypertension, detected by baseline duplex ultrasonography (assessment of direction of flow in right, left and main portal vein [antegrade (normal) or retrograde (abnormal indicative of portal hypertension)]; hemangioma in liver on baseline ultrasonography
  • Untreated proliferative retinopathy
  • Positive pregnancy test, intent for future pregnancy or male subjects' intent to procreate, failure to follow effective contraceptive measures, or presently breast-feeding
  • Evidence of sensitization on PRA (determined by demonstration of positive results for anti-HLA antibodies using solid phase immunoassay with soluble HLA Class I molecules as a target, or a general PRA panel with reactivity >20%)
  • Insulin requirement >0.7 IU/kg/day
  • HbA1C >12%
  • Inability to reach the study hospital for transplantation within 24 hrs of notification
  • Untreated hyperlipidemia (fasting LDL cholesterol >130 mg/dL and/or fasting triglycerides >200 mg/dL)
  • Treated hyperlipidemia that is uncontrolled (fasting LDL cholesterol >130 mg/dL; and/or fasting triglycerides >200 mg/dL)
  • Under treatment for a medical condition requiring chronic use of steroids aa. Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT/INR >1.5
  • 27. Addison's disease. All subjects should be screened with a basal 8:00 a.m. cortisol test. Results less than the lower limit of normal indicate further testing (e.g., a Cortrosyn stimulation test) to rule out adrenal insufficiency. Abnormal ACTH stimulation test will be an exclusion criterion.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Presbyterian Hospital - Weill Cornell Medical Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Human Islet Cell Transplantation in Type 1 Diabetic Patients

The purpose of this study is to test the safety and efficacy of islet cell transplants for the treatment of type 1 diabetes mellitus. It has been shown that normal control of blood sugar levels can prevent progression of complications (such as kidney disease, nerve damage, and vascular disease) from diabetes. This research study is designed to see if normal blood sugar control can be achieved by transplanting pancreatic islet cells into your liver, which may reduce or eliminate your need for insulin. Patients may qualify to participate in this research study if they have type 1 diabetes mellitus for at least five years and meet at least one of the following criteria:

  • Experience hypoglycemic unawareness - Defined as inability to tell when blood glucose is low (for example, may not feel symptoms such as shaking, sweating, and rapid heartbeat that usually signify that glucose is low)
  • Have been hospitalized several times in the past year for low blood sugar and/or high blood sugar
  • Have complications of diabetes such as retinopathy, kidney problems, or neuropathy
Being tested
Islet Cell Transplantation
Keywords
islet cell, diabetes, transplant, immunosuppression, autoimmunity, alloimmunity
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases

What participants receive

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

  • Islet Cell TransplantationDrug

    Islet Cell Transplantation for patients with type 1 diabetes mellitus

Study groups in NCT00303134
Study groupRoleWhat they receive
Islet Cell TransplantationExperimentalNot described
Receives: Drug: Islet Cell Transplantation

What is being measured

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

  1. Insulin independence 12 months after final islet infusion

Secondary outcomes (6)

  1. Basal c-peptide level

  2. Hemoglobin A1c level

  3. Glucose tolerance

  4. C-peptide response to arginine

  5. Mean Amplitude of Glucose Excursion (MAGE)

  6. Mixed meal test

Timeline

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

  1. First posted15 Mar 2006 (estimated)
  2. Study start1 Aug 2003
  3. Primary completion23 Oct 2007
  4. Study completion24 Jun 2010

Why it stopped: poor intermediate-term results

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303134
Sponsor's protocol ID
0105004956
Status last verified
May 2019
First submitted
13 Mar 2006
Last updated
3 Jun 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Islet Cell Transplantation in people with Diabetes Mellitus, Type 1, run by Weill Medical College of Cornell University at 1 site 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 2 inclusion and 34 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 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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: poor intermediate-term results). 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?

Insulin independence 12 months after final islet infusion. 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 NCT00303134.

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 3 Jun 2019.

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