Type 1 DiabetesPhase 2NCT02354911
Autologous Immunoregulatory Dendritic Cells for Type 1 Diabetes Therapy
A Phase 2 study testing Immunoregulatory Dendritic Cells in people with Type 1 Diabetes, run by DiaVacs, Inc..
Trial summary
The purpose of this study is to determine whether dendritic cells collected via leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into the same subject will serve as modulators of the immune system in a manner that disrupts the autoimmune process responsible for the destruction of… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Immunoregulatory Dendritic Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 16 Feb 2024
- Phase
- Phase 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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Fully executed, Institutional Review Board (IRB) approved, informed consent form
- New onset type 1 diabetes randomized within 100 days of diagnosis
- Positive for at least one islet cell auto-antibody; GAD, insulin (if sample within 7 days of the onset of insulin therapy), islet antibody 2 (IA-2), zinc transporter 8 antibody (ZnT8), and/or islet cell antibody (ICA)
- Peak plasma c-peptide concentration >0.2 pmol/mL after ingestion of a standardized mixed meal
- Serologic evidence of prior Epstein-Barr virus (EBV) infection
- Immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro
Show all 9Show fewer
- Adequate peripheral venous access for leukapheresis
- Female participants with childbearing potential must agree to use effective birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception (condom or occlusive cap (diaphragm or cervical cap) + spermicide, or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy).
- Sexually active male participants must agree to use condoms during intercourse
Who cannot join
- History of enrollment in a drug, or biologic therapy clinical trial within past 12 months impacting the immune system
- Prior or current therapy known to cause a significant, ongoing change in the course of type 1 diabetes or immune status
- Evidence of active infection at screening (e.g. "common cold", influenza, hepatitis, tuberculosis, EBV, cytomegalovirus (CMV), herpes simplex virus (HSV), HIV, varicella, chlamydia, evidence of serious fungal infection) or screening laboratory evidence consistent with active microbial, viral, or fungal infection (minor cutaneous fungal infection is not an exclusion)
- Leukopenia (<3,000 leukocytes/microliter, neutropenia (<1,500 neutrophils/microliter), lymphopenia (<800 lymphocytes/microliter) or thrombocytopenia (<125,000 platelets/microliter)
- Positive screen for HIV, tuberculosis, hepatitis B, hepatitis C, herpes simplex virus 1 (HSV1) or herpes simplex virus 2 (HSV2) infection
- Vaccination with any live vaccine product within the 3 months prior to the first cycle of study agent administration
Show all 23Show fewer
- Female subjects pregnant or unwilling to defer pregnancy for the study period
- Females lactating at screening
- History of significant heart disease (e.g., myocardial infarction, coronary artery disease, angina pectoris, arrhythmia, uncontrolled hypertension, congestive heart failure, structural defects)
- Liver disease with alanine transaminase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal
- Impaired renal function with a serum creatinine concentration > 1.5.
- Any other significant immune disorder including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, vitiligo, ankylosing spondylitis and celiac disease. (Thyroiditis treated with a stable dose of thyroid replacement therapy is allowed.)
- Any condition that interferes with accurate measurement of glycated hemoglobin (hemoglobin A1C)
- Any condition that, in the investigator's opinion, may compromise continuous study participation or confound study results
- Any planned vaccinations scheduled prior to end of study participation
- Chronic treatment with systemic corticosteroids (topical or inhaled corticosteroids are allowed)
- Current use of diabetes medications other than insulin
- Anticipated need for any of the following therapies during the 24-month study period:
- Radiation therapy
- Oncologic chemotherapy
- Corticosteroids except for very short courses (≤ 2 weeks)
- Agents used to treat attention deficit and hyperactivity disorder (ADHD)
- Any protein, particle or cell vaccine immunomodulation therapy
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Autologous Immunoregulatory Dendritic Cells in Patients With Type 1 Diabetes
The purpose of this study is to determine whether dendritic cells collected via leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into the same subject will serve as modulators of the immune system in a manner that disrupts the autoimmune process responsible for the destruction of pancreatic beta cells in subjects with new onset type 1 diabetes.
Read the detailed description
This is a double-blind, placebo-controlled cross study designed to evaluate the safety and efficacy of autologous immunoregulatory dendritic cells (iDC) in patients with type 1 diabetes. To do this, a total of 24 subjects with recent onset (<100 days from diagnosis) type 1 diabetes will have circulating dendritic cells harvested via leukapheresis. The harvested dendritic cells will then be incubated in vitro with antisense DNA oligonucleotides targeting the primary transcripts of cluster of differentiation antigen 40 (CD40), cluster of differentiation antigen 80 (CD80) and cluster of differentiation antigen 86 (CD86). These engineered dendritic cells will then be given as autologous intradermal injections (4 injections administered at 2 week intervals) in the subject' peri-umbilical region. The hypothesis is that the injected cells will generate immunoregulatory cells that suppress the autoimmune process responsible for the development of type 1 diabetes via destruction of the subject's pancreatic beta cells.
Employing a cross-over design, all subjects will undergo leukapheresis at the outset. Twelve subjects will be randomly assigned to receive cell injections at the outset while the other 12 subjects will receive sham injections and serve as controls. At the end of 12 months, all subjects will cross-over to the alternative treatment and continue to be followed for an additional 12 months. (Note: The subjects assigned to receive the cell therapy for this segment will receive injections of their autologous cells harvested and engineered at the time of the leukapheresis performed at study entry. The engineered cells will be stored frozen until needed for administration. This design will test whether treatment later (>1 year after diagnosis) is as effective as immediate treatment (<100 days from the diagnosis of type 1 diabetes).
As an added safety measure, the first 6 subjects randomized will all be over the age of 18. When the last of these 6 subjects complete 3 months of observation following the initiation of therapy, the age for enrollment will be lowered to age 16 for the next 6 subjects unless safety observations dictate otherwise. When all subjects in this cohort have been enrolled, the age for enrollment will be lowered to age 14 unless advised otherwise by the independent Data Safety Monitoring Board. When all subjects in this cohort have completed observation for 3 months, the age for enrollment will be lowered to age 12 following clearance by the Data Safety Monitoring Board.
If this therapy is successful, the subjects' remaining beta cell mass will be preserved and hopefully expanded once the autoimmune process is slowed or stopped. This outcome will be assessed indirectly using plasma c-peptide concentrations following ingestion of a standardized mixed meal at the end of 12 and 24 months of therapy. If the treatment is successful, glucose control should improve and be detectable via measurement of hemoglobin A1c (measure of long-term control), fasting plasma glucose concentrations and the plasma glucose concentrations following ingestion of the standardized mixed meal. In addition, the total daily insulin requirements should decrease. These measures of glucose control will be assessed at baseline and then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Immune markers will also be profiled at 3 month intervals to assess potential tolerogenic effects of the therapy. To this end, numbers of potentially tolerogenic/regulatory T-cells, B-cells and dendritic cells in the circulating peripheral blood monocyte population will be assessed. In addition, analysis of selected populations of T-cells, B-cells and dendritic cells will be conducted over the entire study period in an attempt to identify molecular signatures correlated with the clinical response.
Finally, in addition to the routine safety laboratory measurements, all reported adverse events will be examined in detail to characterize the safety aspects of the therapy. The review of these safety data will be guided by an independent Data Safety Monitoring Board which will meet at least semi-annually to review the accrued data.
- Conditions
- Type 1 Diabetes
- Being tested
- Immunoregulatory Dendritic Cells, Placebo Comparator: Placebo Control
- Keywords
- Immunomodulation
- 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.
Immunoregulatory Dendritic CellsBiological
Also called iDC
Autologous dendritic cells harvested by leukapheresis and engineered ex vivo via incubation with antisense DNA oligonucleotides targeting the primary transcripts of CD40, CD80 and CD86. The ex vivo engineered product is then administered via blinded intradermal injection in the peri-umbilical region of the abdomen given as 4 separate injections at 2-week intervals (~10 million cells/injection).
Placebo Comparator: Placebo ControlOther
Blinded intradermal injections in the peri-umbical region of the abdomen given as 4 separate injections at 2-week intervals
| Study group | Role | What they receive |
|---|---|---|
| Immunoregulatory Dendritic Cells (iDC) | Experimental | Biological intervention consisting of autologous dendritic cells treated in vitro to convert to active immunoregulatory dendritic cells. Receives: Biological: Immunoregulatory Dendritic Cells |
| Placebo Control | Placebo comparator | Saline injections administered blinded to subject and all study staff except for research pharmacist who is not involved in study conduct Receives: Other: Placebo Comparator: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean 2-hour area under the curve (AUC) for plasma c-peptide at 12 and 24 months
Mean 2-hour area under the time-concentration curve for plasma c-peptide following ingestion of a standardized mixed meal compared across treatment groups at end of Segment 1 (12 months) and Segment 2 (24 months)
Measured: 12 and 24 months
Secondary outcomes (9)
Reported adverse events
All reported adverse events for treatment compared to placebo control group across each treatment period
Measured: 12 months; 12 to 24 months and 0 to 24 months
Change from baseline in number of potentially-tolerogenic/regulatory T-cells, B-cells and dendritic cells in circulating peripheral blood mononuclear cell fraction
Numbers of potentially-tolerogenic/regulatory T-cells, B-cells and dendritic cells in circulating peripheral blood mononuclear cell fraction assessed at 3 month intervals over the course of both treatment periods based on defined cell markers
Measured: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of T-cells
Sub-populations of T-cells in iDC treatment group compared to placebo group assessed at 3 month intervals throughout the course of both segments of the trial
Measured: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of B-cells
Sub-populations of B-cells in iDC treatment group compared to placebo group assessed at 3 month intervals throughout the course of both segments of the trial
Measured: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of dendritic cells
Sub-populations of dendritic cells in iDC treatment group compared to placebo group assessed at 3 month intervals throughout the course of both segments of the trial
Measured: 3,6,9,12,15,18,21 and 24 months
Change from baseline in Fasting Plasma Glucose
Plasma glucose concentration following an overnight fast of at least 8 hours duration
Measured: 3, 6, 9, 12,15,18,21, and 24 months
Change from baseline in Hemoglobin A1c
Measurement of hemoglobin A1c is the well-established measure of glucose control reflecting the "integrated" glycemic exposure over the past 90 to 120 days
Measured: 3, 6, 9, 12,15,18,21, and 24 months
Change from baseline in the baseline corrected, 2-hour AUC for glucose at 12 and 24 months
Baseline corrected, 2-hour AUC for plasma glucose following ingestion of a standardized mixed meal
Measured: 12 and 24 months
Change from baseline in Total Daily Insulin Dose
The cumulative total daily insulin dose collected as the average for the 3-day period immediately prior to the respective clinic visits. This includes all forms of insulin used by the subject
Measured: 3, 6, 9, 12,15,18,21, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startOct 2015
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Why it stopped: Funding for study not procured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaVacs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West Penn Allegheny Health System, University of Pittsburgh Medical Center, Stanford University, University of Miami
- Responsible party
- Sponsor
- Investigators
- Massimo Trucco, PhD, Study chair, Institue of Cellular Therapeutics, Allegheny General Hospital, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354911
- Sponsor's protocol ID
- DV-0100-101
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2015
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Phillips BE, Garciafigueroa Y, Engman C, Trucco M, Giannoukakis N. Tolerogenic Dendritic Cells and T-Regulatory Cells at the Clinical Trials Crossroad for the Treatment of Autoimmune Disease; Emphasis on Type 1 Diabetes Therapy. Front Immunol. 2019 Feb 6;10:148. doi: 10.3389/fimmu.2019.00148. eCollection 2019.
PubMed 30787930
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Safety and Efficacy of Autologous Immunoregulatory Dendritic Cells in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02354911
- Acronym / sponsor ID
- DV-0100-101
- Conditions
- Type 1 Diabetes
- Keywords
- Immunomodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for study not procured.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DiaVacs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- West Penn Allegheny Health System, University of Pittsburgh Medical Center, Stanford University, University of Miami
- Study start
- Oct 2015
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether dendritic cells collected via leukapheresis and incubated with antisense DNA oligonucleotides and then injected back into the same subject will serve as modulators of the immune system in a manner that disrupts the autoimmune process responsible for the destruction of pancreatic beta cells in subjects with new onset type 1 diabetes.
Detailed description
This is a double-blind, placebo-controlled cross study designed to evaluate the safety and efficacy of autologous immunoregulatory dendritic cells (iDC) in patients with type 1 diabetes. To do this, a total of 24 subjects with recent onset (<100 days from diagnosis) type 1 diabetes will have circulating dendritic cells harvested via leukapheresis. The harvested dendritic cells will then be incubated in vitro with antisense DNA oligonucleotides targeting the primary transcripts of cluster of differentiation antigen 40 (CD40), cluster of differentiation antigen 80 (CD80) and cluster of differentiation antigen 86 (CD86). These engineered dendritic cells will then be given as autologous intradermal injections (4 injections administered at 2 week intervals) in the subject' peri-umbilical region. The hypothesis is that the injected cells will generate immunoregulatory cells that suppress the autoimmune process responsible for the development of type 1 diabetes via destruction of the subject's pancreatic beta cells.
Employing a cross-over design, all subjects will undergo leukapheresis at the outset. Twelve subjects will be randomly assigned to receive cell injections at the outset while the other 12 subjects will receive sham injections and serve as controls. At the end of 12 months, all subjects will cross-over to the alternative treatment and continue to be followed for an additional 12 months. (Note: The subjects assigned to receive the cell therapy for this segment will receive injections of their autologous cells harvested and engineered at the time of the leukapheresis performed at study entry. The engineered cells will be stored frozen until needed for administration. This design will test whether treatment later (>1 year after diagnosis) is as effective as immediate treatment (<100 days from the diagnosis of type 1 diabetes).
As an added safety measure, the first 6 subjects randomized will all be over the age of 18. When the last of these 6 subjects complete 3 months of observation following the initiation of therapy, the age for enrollment will be lowered to age 16 for the next 6 subjects unless safety observations dictate otherwise. When all subjects in this cohort have been enrolled, the age for enrollment will be lowered to age 14 unless advised otherwise by the independent Data Safety Monitoring Board. When all subjects in this cohort have completed observation for 3 months, the age for enrollment will be lowered to age 12 following clearance by the Data Safety Monitoring Board.
If this therapy is successful, the subjects' remaining beta cell mass will be preserved and hopefully expanded once the autoimmune process is slowed or stopped. This outcome will be assessed indirectly using plasma c-peptide concentrations following ingestion of a standardized mixed meal at the end of 12 and 24 months of therapy. If the treatment is successful, glucose control should improve and be detectable via measurement of hemoglobin A1c (measure of long-term control), fasting plasma glucose concentrations and the plasma glucose concentrations following ingestion of the standardized mixed meal. In addition, the total daily insulin requirements should decrease. These measures of glucose control will be assessed at baseline and then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Immune markers will also be profiled at 3 month intervals to assess potential tolerogenic effects of the therapy. To this end, numbers of potentially tolerogenic/regulatory T-cells, B-cells and dendritic cells in the circulating peripheral blood monocyte population will be assessed. In addition, analysis of selected populations of T-cells, B-cells and dendritic cells will be conducted over the entire study period in an attempt to identify molecular signatures correlated with the clinical response.
Finally, in addition to the routine safety laboratory measurements, all reported adverse events will be examined in detail to characterize the safety aspects of the therapy. The review of these safety data will be guided by an independent Data Safety Monitoring Board which will meet at least semi-annually to review the accrued data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoregulatory Dendritic Cells (iDC) | Experimental | Biological: Immunoregulatory Dendritic CellsBiological intervention consisting of autologous dendritic cells treated in vitro to convert to active immunoregulatory dendritic cells. |
| Placebo Control | Placebo comparator | Other: Placebo Comparator: Placebo ControlSaline injections administered blinded to subject and all study staff except for research pharmacist who is not involved in study conduct |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Fully executed, Institutional Review Board (IRB) approved, informed consent form
- New onset type 1 diabetes randomized within 100 days of diagnosis
- Positive for at least one islet cell auto-antibody; GAD, insulin (if sample within 7 days of the onset of insulin therapy), islet antibody 2 (IA-2), zinc transporter 8 antibody (ZnT8), and/or islet cell antibody (ICA)
- Peak plasma c-peptide concentration >0.2 pmol/mL after ingestion of a standardized mixed meal
- Serologic evidence of prior Epstein-Barr virus (EBV) infection
Key exclusion criteria (23 listed)
- History of enrollment in a drug, or biologic therapy clinical trial within past 12 months impacting the immune system
- Prior or current therapy known to cause a significant, ongoing change in the course of type 1 diabetes or immune status
- Evidence of active infection at screening (e.g. "common cold", influenza, hepatitis, tuberculosis, EBV, cytomegalovirus (CMV), herpes simplex virus (HSV), HIV, varicella, chlamydia, evidence of serious fungal infection) or screening laboratory evidence consistent with active microbial, viral, or fungal infection (minor cutaneous fungal infection is not an exclusion)
- Leukopenia (<3,000 leukocytes/microliter, neutropenia (<1,500 neutrophils/microliter), lymphopenia (<800 lymphocytes/microliter) or thrombocytopenia (<125,000 platelets/microliter)
- Positive screen for HIV, tuberculosis, hepatitis B, hepatitis C, herpes simplex virus 1 (HSV1) or herpes simplex virus 2 (HSV2) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoregulatory Dendritic CellsAlso: iDCAutologous dendritic cells harvested by leukapheresis and engineered ex vivo via incubation with antisense DNA oligonucleotides targeting the primary transcripts of CD40, CD80 and CD86. The ex vivo engineered product is then administered via blinded intradermal injection in the peri-umbilical region of the abdomen given as 4 separate injections at 2-week intervals (~10 million cells/injection). | Biological | Immunoregulatory Dendritic Cells (iDC) |
| Placebo Comparator: Placebo ControlBlinded intradermal injections in the peri-umbical region of the abdomen given as 4 separate injections at 2-week intervals | Other | Placebo Control |
Primary outcome
Change from baseline in the mean 2-hour area under the curve (AUC) for plasma c-peptide at 12 and 24 months
Time frame: 12 and 24 months
Mean 2-hour area under the time-concentration curve for plasma c-peptide following ingestion of a standardized mixed meal compared across treatment groups at end of Segment 1 (12 months) and Segment 2 (24 months)
9 secondary outcomes
Reported adverse events
Time frame: 12 months; 12 to 24 months and 0 to 24 months
Change from baseline in number of potentially-tolerogenic/regulatory T-cells, B-cells and dendritic cells in circulating peripheral blood mononuclear cell fraction
Time frame: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of T-cells
Time frame: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of B-cells
Time frame: 3,6,9,12,15,18,21 and 24 months
Change from baseline in sub-populations of dendritic cells
Time frame: 3,6,9,12,15,18,21 and 24 months
Change from baseline in Fasting Plasma Glucose
Time frame: 3, 6, 9, 12,15,18,21, and 24 months
Change from baseline in Hemoglobin A1c
Time frame: 3, 6, 9, 12,15,18,21, and 24 months
Change from baseline in the baseline corrected, 2-hour AUC for glucose at 12 and 24 months
Time frame: 12 and 24 months
Change from baseline in Total Daily Insulin Dose
Time frame: 3, 6, 9, 12,15,18,21, and 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 30787930Phillips BE, Garciafigueroa Y, Engman C, Trucco M, Giannoukakis N. Tolerogenic Dendritic Cells and T-Regulatory Cells at the Clinical Trials Crossroad for the Treatment of Autoimmune Disease; Emphasis on Type 1 Diabetes Therapy. Front Immunol. 2019 Feb 6;10:148. doi: 10.3389/fimmu.2019.00148. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Trucco, PhD study chair
Institue of Cellular Therapeutics, Allegheny General Hospital, Pittsburgh, PA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunoregulatory Dendritic Cells in people with Type 1 Diabetes, run by DiaVacs, Inc..
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 9 inclusion and 23 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: withdrawn, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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 withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in the mean 2-hour area under the curve (AUC) for plasma c-peptide at 12 and 24 months (time frame: 12 and 24 months). 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 NCT02354911, which also lists 1 linked publication.
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 20 Feb 2024.