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Stem Cell Therapy

VX-880 for Type 1 Diabetes

Phase 1 & 2
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
Clinical history of T1D with > 5 years of duration
Timeline
Screening 3 days
Treatment Varies
Follow Up from vx-880 infusion to end of study (up to 5 years)
Awards & highlights

Study Summary

This trial will study if VX-880 is safe and effective in people with Type 1 diabetes who have impaired awareness of low blood sugar and have had severe hypoglycemia.

Who is the study for?
This trial is for people with Type 1 diabetes who've had it for over 5 years and have trouble sensing when their blood sugar gets too low. They should have had at least two serious low blood sugar events in the past year and must be using a continuous glucose monitor (CGM) for three months before, and during, the study.Check my eligibility
What is being tested?
The trial is testing VX-880's safety and effectiveness. Participants will receive an infusion of VX-880 to see if it helps manage Type 1 diabetes, especially for those who often don't notice when their blood sugar drops dangerously low.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, changes in blood sugar levels that could lead to hypoglycemia or hyperglycemia, immune responses against the infused cells, or other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least two severe low blood sugar episodes in the last year.
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I have had Type 1 Diabetes for more than 5 years.

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~from vx-880 infusion to end of study (up to 5 years)
This trial's timeline: 3 days for screening, Varies for treatment, and from vx-880 infusion to end of study (up to 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Changes in Stimulated C-peptide
Proportion of Participants who are Insulin Independent

Trial Design

1Treatment groups
Experimental Treatment
Group I: VX-880Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,370 Total Patients Enrolled

Media Library

VX-880 (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04786262 — Phase 1 & 2
Type 1 Diabetes Research Study Groups: VX-880
Type 1 Diabetes Clinical Trial 2023: VX-880 Highlights & Side Effects. Trial Name: NCT04786262 — Phase 1 & 2
VX-880 (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786262 — Phase 1 & 2
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT04786262 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different medical clinics is this research study being conducted today?

"So far, 11 locations have recruited patients for this trial. For example, there are participants from Massachusetts General Hospital in Boston, University of Wisconsin in Madison, and Hospital of the University of Pennsylvania in Philadelphia."

Answered by AI

Can people with the specified condition still sign up for this trial?

"Yes, the clinical trial is still recruiting patients. According to information on clinicaltrials.gov, the trial was first posted on 3/29/2021 and was last edited on 8/8/2022. So far, 17 participants have been recruited from 11 different sites."

Answered by AI

Does this study have an age requirement?

"The current enrolment phase for this clinical trial includes people aged 18-65."

Answered by AI

How many participants are being recruited for this research?

"As specified by the sponsor, Vertex Pharmaceuticals Incorporated, a total of 17 patients that meet this trial's inclusion criteria are required in order to run the study from various locations - such as Massachusetts General Hospital in Boston, Wisconsin and University of Wisconsin in Madison, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
New York
California
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
UHealth Diabetes Research Institute
Hospital of the University of Pennsylvania
VCU Medical Center, Richmond
Other
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I want to help because I hate having diabetes. I want to comming out from insulin and want to show world that T1D CAN be cure.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. VCU Medical Center, Richmond: < 24 hours
  2. City of Hope: < 48 hours
  3. Hospital of the University of Pennsylvania: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
2021. "A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04786262.
All > Type 1 Diabetes
~4 spots leftby Apr 2025
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