Crohn Disease
Stem Cell Transplantation for Treatment-Resistant Crohn's Disease
This study is investigating the safety and potential clinical benefit of immune-system ablation followed by autologous hematopoietic stem cell transplantation in people ages 13–28 with treatment-resistant Crohn's disease.
Registry title: Stem Cell Transplantation in Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 13 Years–28 Years
- Treatment
- Mesna or Cyclophosphamide
- Design
- Not provided
- Central study contact
- David Ziring, MD310-423-7100david.ziring@cshs.org
- Sponsor
- Cedars-Sinai Medical Center
Research question
What safety outcomes and potential clinical effects occur when treatment-resistant Crohn's disease is treated with lymphocyte ablation followed by transplantation of the participant's own blood-forming stem cells?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 13–28.
- The study is looking for people with Crohn's disease diagnosed at least six months before screening.
- The study is looking for people with active Crohn's disease meeting the registry's symptom-score requirement plus at least two specified laboratory, endoscopic, histologic, or imaging findings.
- The study is looking for people whose disease course has remained unsatisfactory despite corticosteroids and three immunosuppressive or biologic agents, or who have documented intolerance or toxicity.
- The listed recruiting location is Cedars-Sinai Medical Center in Los Angeles, California.
Participation overview
What participation may involve
Participants undergo stem-cell mobilization and collection, immune-system conditioning, infusion of their own peripheral blood stem cells, post-infusion conditioning, and follow-up assessments of safety, Crohn's disease activity, quality of life, productivity, and immune-system measures. What participation may involve: - Receive medicines for stem-cell mobilization, conditioning, premedication, and post-infusion care. - Have an apheresis catheter placed and undergo leukapheresis to collect peripheral blood stem cells. - Receive an infusion of the participant's own collected peripheral blood stem cells. - Undergo Crohn's disease assessments that include ileocolonoscopy, inflammatory-marker testing, symptom and disease-activity measures, and stool calprotectin testing. - Complete quality-of-life and school or work productivity questionnaires and provide samples for immune-system analyses. The registry reports outcome assessments through 24 months after stem-cell transplantation, but it does not clearly state the complete participation period.
Study interventions
What participants may receive or do
- Mesna: Mesna is infused during stem-cell mobilization and is also given with Cytoxan after the stem-cell infusion according to institutional protocols.
- Cyclophosphamide: Cyclophosphamide is given intravenously over two consecutive days as part of stem-cell mobilization.
- Filgrastim: Filgrastim is given during stem-cell mobilization and again after the stem-cell infusion until a specified neutrophil count is reached.
- Apheresis catheter placement: An interventional radiologist places an apheresis catheter on the day stem cells are collected.
- Leukapheresis: A continuous-flow cell-separation machine is used to collect a target quantity of CD34-positive blood-forming stem cells.
- Fludarabine: Fludarabine is given for four days as part of the preparative conditioning regimen before stem-cell infusion.
- Methylprednisolone: Methylprednisolone is given as premedication for rabbit anti-thymocyte globulin according to institutional guidelines.
- Diphenhydramine: Diphenhydramine is given as premedication for rabbit anti-thymocyte globulin according to institutional guidelines.
- Acetaminophen: Acetaminophen is given as premedication for rabbit anti-thymocyte globulin according to institutional guidelines.
- anti-thymocyte globulin (rabbit): Rabbit anti-thymocyte globulin is infused on three specified days as part of the conditioning regimen.
- lymphocyte immune globulin: Horse anti-thymocyte globulin may replace rabbit anti-thymocyte globulin if a participant develops a severe allergic reaction to the rabbit product.
- Peripheral Blood Stem Cell Infusion: The participant's collected peripheral blood stem cells are infused on the day designated as day 0.
- Cytoxan: Cytoxan, another registry name for cyclophosphamide, is infused for two days after the peripheral blood stem-cell infusion with hydration or according to institutional guidelines.
Study design
How the comparison works
This phase 1/phase 2 prospective study places all participants in one experimental treatment group receiving stem-cell mobilization, conditioning, and autologous stem-cell transplantation. The study is non-randomized; everyone is assigned to the single treatment group. The study is open-label with no masking, so participants and study personnel know which treatment is given. The registry describes one experimental group and no separate control or comparator group. No placebo group or placebo intervention is described in the registry record.
Reported activities
Procedures and tests
- Apheresis catheter placement on the day of stem-cell collection.
- Leukapheresis using a continuous-flow separator to collect CD34-positive cells.
- Peripheral blood stem-cell infusion on day 0.
- Ileocolonoscopy with Simple Endoscopic Score for Crohn's Disease assessment at baseline, six months, and 12 months after transplantation.
- Blood testing for erythrocyte sedimentation rate and C-reactive protein.
- Stool testing for fecal calprotectin concentration.
- Crohn's Disease Activity Index assessments using symptoms, history, examination findings, and laboratory measures.
- Monitoring and recording of treatment-emergent adverse events, severe toxicity, death, viral reactivation, and fungal infection.
- IMPACT-III quality-of-life questionnaire.
- Modified Work Productivity and Activity Impairment questionnaire for school, work, and activity effects.
- Immune-system testing for T-cell receptor excision circles and T-cell repertoire using spectratyping.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 13–28 years old.
- Crohn's disease must have been diagnosed using typical radiology and/or histology at least six months before screening.
- At registration, active disease must include a Pediatric Crohn's Disease Activity Index above 30 plus at least two of three specified findings: elevated C-reactive protein, histology-confirmed active endoscopic disease, or active small-bowel disease on CT or MR enterography.
- The disease course must have remained unsatisfactory despite corticosteroids and three immunosuppressive agents, with relapsing disease despite maintenance therapy or clear intolerance or toxicity to the listed drugs.
- Current problems must be unsuitable for surgery, or the person must be at risk of developing short bowel syndrome.
- A majority of the combined inflammatory bowel disease center members must accept the person as an appropriate candidate.
- Participants must provide informed consent, be prepared for the scheduled study procedures, and undergo intensive counseling about risks.
Possible reasons someone may not be able to join
- Pregnancy or unwillingness to use adequate contraception during the study excludes participation; the criterion applies to women of childbearing age and requires appropriate contraception from males.
- Specified severe kidney, heart, or lung disease excludes participation, including creatinine clearance below 30 mL/min, left ventricular ejection fraction below 40%, or lung diffusion capacity below 40%.
- Psychiatric disorders including active drug or alcohol abuse, recent or current malignancy other than non-melanoma skin cancer, uncontrolled hypertension, or another chronic disease causing significant organ failure excludes participation.
- Infection with HIV, human T-cell lymphotropic virus types 1 or 2, hepatitis viruses, or another infection considered a contraindication by investigators excludes participation.
- A clinically relevant abscess, significant active infection, tuberculosis history or increased risk, evidence of active tuberculosis, or a chest X-ray consistent with infection or cancer excludes participation.
- A perianal fistula without free drainage excludes participation; a fistula with natural free drainage or a seton does not automatically exclude participation.
- Significant malnutrition, defined as body mass index at or below 18 or serum albumin below 20 g/L, excludes participation.
- Previous poor compliance excludes participation.
- Enrollment in another protocol using an investigational drug or blood-cell growth factor within four weeks before study entry excludes participation.
Important unknowns
What the record does not make clear
- The record lists assessment time points through 24 months but does not provide a complete visit schedule, visit length, hospitalization schedule, or number of visits.
- Outcomes are measured through 24 months after transplantation, but the record does not clearly define when all participation ends.
- The record does not state which existing Crohn's disease treatments may continue before, during, or after transplantation.
- A four-week restriction is stated for another investigational-drug or hematopoietic-growth-factor protocol, but washout requirements for current Crohn's disease medicines are not reported.
- The record does not explain what rescue treatment is available if Crohn's disease worsens or a transplant complication develops.
- The record describes ileocolonoscopy at six and 12 months and an endoscopic baseline outcome, but does not report preparation, sedation, biopsy requirements, or whether additional endoscopies may be needed.
- The record does not state which study treatments, procedures, hospital care, or complication-related care are paid by the study or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not report support for travel, lodging, meals, parking, or caregiver expenses.
- The record identifies one Los Angeles site but does not say whether any screening or follow-up can occur remotely or through a local clinician.
- The record does not describe medical follow-up or access to study-related care after participation ends.
Before contacting the site
Questions for the study team
- What is the full timeline for mobilization, stem-cell collection, conditioning, transplantation, hospitalization, and follow-up?
- Which current Crohn's disease medicines must be stopped or changed, and what washout periods apply?
- What short- and long-term risks are expected from mobilization, conditioning, stem-cell infusion, and post-infusion treatment, and how are complications managed?
- What rescue care is available if Crohn's disease worsens during treatment or follow-up?
- How many ileocolonoscopies are required, and will they involve sedation, biopsies, or overnight care?
- Which study-related treatments, hospital stays, tests, and complication-related care are covered, and what might be billed to insurance?
- Can any screening or follow-up occur remotely or with a local gastroenterologist, and is travel or lodging support available?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease now, and how does its current severity compare with the study's active-disease requirements?
- Have my previous treatments and their outcomes been fully documented, and are there approved treatment or surgical alternatives still worth discussing?
- What could happen if my current Crohn's medicines are paused or changed for screening or transplantation?
- How might my infection history, nutrition, heart, lung, kidney, or other health conditions affect the risks of this study?
- If I contact the study team, how would you coordinate my ongoing Crohn's care, medication decisions, and management of a disease flare with them?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT). This study removes over active lymphocytes (immunoablation) and replaces them using blood stem cells that have been taken from the patient's own body. The aim of the study is to reset or reprogram the patient's immune system to its state prior to diagnosis.
The treatment of Crohn's disease has proven to be quite efficacious in the majority of patients with the timely use of combination therapies for remission induction (corticosteroids and/or biologics) and maintenance of disease control (immunosuppressives and/or biologics). However, a proportion of patients fail to achieve complete and long term disease control and often require multiple intestinal surgeries with a risk of developing short bowel syndrome. Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system has been proposed as an alternative strategy to induce long term disease control in this high-risk population. It has been demonstrated that despite the potential toxicity and morbidity associated with the procedure, the benefit-risk ratio is favorable. Hence, the investigators propose to offer HSCT to selected CD patients and to study mechanisms of reducing T cell autoreactivity which will hopefully lead to more focused therapeutic approaches in the future. This is an open-label, non-randomized, non-blinded, prospective study in therapeutic refractory Crohn's patients, failing conventional therapy. The primary objective is to evaluate the safety and potential clinical benefit of lymphoablation followed by autologous HSCT rescue in therapy refractory CD. Death (transplant-related mortality, TRM) and severe toxicity (≥ grade 3 toxicity; NCI Toxicity Criteria version 4.0) within the first 6 months after HSCT will be monitored to meet this end-point. SECONDARY OBJECTIVES 1. To evaluate the incidence of HSCT related complications, i.e. viral reactivations (CMV, Adenovirus, EBV, BK virus) or fungal infections. 2. To evaluate the impact of HSCT on quality of life and school productivity. 3. To elucidate the underlying mechanism involved in the observed benefit of HSCT on CD. First, the safety will be evaluated by the amount of related adverse events. All adverse events will be recorded in a standardized way and their relationship to the study protocol will be assessed at various short and long term time points. Second, to determine clinical benefit, the percentage of patients in sustained disease remission at 0, 2, 4, 6, 12 and 24 months post HSCT will be determined. Sustained disease remission is defined as a Crohn's Disease Activity Index (CDAI) \< 150 without the use of corticosteroids. In addition, mucosal healing will be assessed during ileocolonoscopy at 6 and 12 months following HSCT using the CD endoscopic index (SES). SECONDARY ENDPOINTS \- Change in Crohn's disease endoscopic index after 6 and 12 months.
Study design and administration
- Organization
- Cedars-Sinai Medical Center
- Organization class
- Other
- Organization study ID
- Pro00051458
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult
Study arms
Experimental
HSCT after mobilization and conditioning
Mobilization and leukopheresis allow for stem cell harvest. Then conditioning is provided prior to stem cell transplantation, followed by post-transplant conditioning. Interventions include: 1. Stem cell mobilization 2. Leukopheresis 3. Preparative regimen 4. Peripheral blood stem cell infusion 5. Post-PBSC infusion conditioning
Interventions: Drug: Mesna, Drug: Cyclophosphamide, Drug: Filgrastim, Procedure: Apheresis catheter placement, Procedure: Leukapheresis, Drug: Fludarabine, Drug: Methylprednisolone, Drug: Diphenhydramine, Drug: Acetaminophen, Drug: anti-thymocyte globulin (rabbit), Drug: lymphocyte immune globulin, Biological: Peripheral Blood Stem Cell Infusion, Drug: Cytoxan
Interventions
Drug
Mesna
Stem Cell Mobilization: Infused according to institutional guidelines; Post-PBSC Infusion Conditioning: Mesna provided with Cytoxan according to institutional protocol.
Drug
Cyclophosphamide
Stem Cell Mobilization: Cyclophosphamide (CY) infused intravenously over 1 hour: 50 mg/kg (25 mg/kg/day on 2 consecutive days)
Drug
Filgrastim
Stem Cell Mobilization: Filgrastim (G-CSF) 10 mcg/kg SC will start 5 days after the last dose of CY and will end the day before the last leukapheresis; Post-PBSC Infusion Conditioning: Filgrastim administered intravenously 5 mcg/kg IV starting day + 5, continue until ANC of \>1000/μL
Procedure
Apheresis catheter placement
Subjects will require placement of an Apheresis catheter by Intervention Radiologists on the day of collection of stem cells.
Procedure
Leukapheresis
Leukapheresis will be performed on a continuous flow separator machine according to institutional guidelines to target 3-8 x 10\^6 CD34+ cells/kg body weight.
Drug
Fludarabine
Preparative/Conditioning Regime Fludarabine given as 30 mg/m2 per dose x 4 days, beginning on day -6.
Drug
Methylprednisolone
Preparative/Conditioning Regime r-ATG pre-medication according to institutional guidelines
Drug
Diphenhydramine
Preparative/Conditioning Regime r-ATG premedication according to institutional guidelines
Drug
Acetaminophen
Preparative/Conditioning Regime r-ATG premedication according to institutional guidlines
Drug
anti-thymocyte globulin (rabbit)
Preparative/Conditioning Regime r-ATG administered intravenously: 2.5 mg/kg/dose IV over 6 hours on specified days (day -6,-4,-2); ); total 3 doses=7.5 mg/kg.
Drug
lymphocyte immune globulin
Preparative/Conditioning Regime In patients who develop severe allergic reactions to rATG (Thymoglobulin), it may be substituted by horse ATG (hATG, ATGAM, Pharmacia \& Upjohn, Kalamazoo, MI). The recommended dose of hATG is 25 mg/kg/day for 3 doses.
Biological
Peripheral Blood Stem Cell Infusion
PBSC (peripheral blood stem cell) infusion on day 0 as per institutional guidelines.
Drug
Cytoxan
Post-PBSC Infusion Conditioning Cytoxan infused intravenously: 50mg/kg/day x 2 days. Infused over 2 hours with adequate hydration or according to institutional guidelines.
Eligibility
13 Years–28 Years
All
Not accepted
Inclusion criteria (14)
- Aged 13-28 years are eligibleRegistry-derived · unreviewed
- Confirmed diagnosis of active Crohn's disease:Registry-derived · unreviewed
- Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening.Registry-derived · unreviewed
- Active disease at the time of registration to the trial, defined asRegistry-derived · unreviewed
- PCDAI \> 30, and ii) Two of the following:Registry-derived · unreviewed
- elevated CRPRegistry-derived · unreviewed
- endoscopic evidence of active disease confirmed by histologyRegistry-derived · unreviewed
- clear evidence of active small bowel Crohn's disease on CT or MR enterography.Registry-derived · unreviewed
- Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab, adalimumab and/or certolizumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. 1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab/adalimumab/certolizumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.Registry-derived · unreviewed
- Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome.Registry-derived · unreviewed
- Accepted by a majority of the members of the combined IBD Center as an appropriate candidate (see Selection description below).Registry-derived · unreviewed
- Informed consentRegistry-derived · unreviewed
- Prepared to undergo additional study procedures as per trial scheduleRegistry-derived · unreviewed
- Patient has undergone intensive counseling about risksRegistry-derived · unreviewed
Exclusion criteria (17)
- Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate contraceptive measures in males.Registry-derived · unreviewed
- Concomitant severe diseaseRegistry-derived · unreviewed
- renal: creatinine clearance \< 30 mL/min (measured or estimated)Registry-derived · unreviewed
- cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction \< 40% by cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echo cardiographerRegistry-derived · unreviewed
- pulmonary: diffusion capacity \<40%Registry-derived · unreviewed
- psychiatric disorders including active drug or alcohol abuseRegistry-derived · unreviewed
- concurrent or recent history of malignant disease (excluding non-melanoma skin cancer)Registry-derived · unreviewed
- uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140 and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensive agents.Registry-derived · unreviewed
- any infection with HIV, HTLV-1 or 2, hepatitis viruses, or any other infection the investigators consider a contraindication to participation.Registry-derived · unreviewed
- other chronic disease causing significant organ failure.Registry-derived · unreviewed
- Infection or risk thereof:Registry-derived · unreviewed
- Current clinical relevant abscess or significant active infection.Registry-derived · unreviewed
- History of tuberculosis or at current increased risk of tuberculosisRegistry-derived · unreviewed
- Quantiferon Gold test result or other investigations that the investigators regard as evidence of active tuberculosis.Registry-derived · unreviewed
- Abnormal chest X-ray (CXR) consistent with active infection or neoplasm.Registry-derived · unreviewed
- 6\) Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin \< 20 g/l.Registry-derived · unreviewed
- 7\) Previous poor compliance. 8) Concurrent enrollment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Change in mucosal healing
Time frame: Change from pre-HSCT (baseline) to 6 months and 12 months post HSCT
Change mucosal healing as determined by the simple endoscopic score for crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each are measured on a scale of 0-3 and are summed to create a total score. For total score, 0-2 indicates remission, 3-6 indicates mild endoscopic activity, 7-15 indicates moderate endoscopic activity, and \> 15 indicates severe endoscopic activity.
Primary outcome
Change in erythrocyte sedimentation rate (SED rate)
Time frame: Change from pre-HSCT (baseline) to 2, 4, 6, 12, and 24 months post HSCT
Change in SED rate (mm/hour)
Primary outcome
Change in fecal calprotectin concentration
Time frame: Change from pre-HSCT (baseline) to 2, 4, 6, 12, and 24 months post HSCT
Change in fecal calprotectin concentration
Primary outcome
Change in C reactive protein (CRP)
Time frame: Change from pre-HSCT (baseline) to 2, 4, 6, 12, and 24 months post HSCT
Change in C reactive protein (CRP)
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 24 months post HSCT
Number of treatment-emergent adverse events (including death (transplant related mortality, TRM) and severe toxicity (≥ grade 3 toxicity; NCI Toxicity Criteria version 4.0)
Primary outcome
Incidence of HSCT Related Complications
Time frame: Up to 24 months post HSCT
The incidence of HSCT related complications, i.e. viral reactivations (CMV, Adenovirus, EBV, BK virus) or fungal infections.
Primary outcome
Change in clinical measures of sustained remission
Time frame: Up to 24 months post HSCT
Change in CDAI score (Crohn's Disease Activity Index). The CDAI measure the signs, symptoms, and history of Crohn's Disease based on the past 7 days. The index measures abdominal pain, stools per day, general wellbeing, HCT, ESR, Albumin, height, weight, abdominal exam, perirectal disease, and extra-intestinal manifestations each scaled between 0-10. The sum of these measures creates a total score between 0-100 with the higher score representative of more disease activity.
Secondary outcome
Change in quality of life
Time frame: 0, 2, 4, 6, 12 and 24 months post HSCT
Change in score on the IMPACT-III Questionnaire (A Quality of Life Questionnaire for Children with Inflammatory Bowel Disease) after HSCT. It is a self-report measure with 35 closed questions encompassing six proposed domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
Secondary outcome
Change in school and work productivity
Time frame: 0, 2, 4, 6, 12 and 24 months post HSCT
Change in school productivity and activity impairment as determined by the modified Work Productivity and Activity Impairment (WPAI) Index score. The Modified WPAI yield four types of scores: absenteeism (school time missed), presenteeism (impairement at school), school productivity (overall work impairment/absenteeism plus presenteeism), and activity impairement. WPAI outcomes are expressed as impairement percentages, with higher numbers indicating greater impairement and less productivity.
Secondary outcome
Change in thymopoiesis after HSCT
Time frame: 0, 2, 4, 6, 12 and 24 months post HSCT
the amount of T-cell receptor excision circles (TREC) will be determined. TRECs are excision circles of DNA excised during the process of T cell receptor (TCR) rearrangement. Since these TRECs do not replicate during cell division, they can also be a measure for recent thymic emigrants.
Secondary outcome
Change in T-cell repertoire after HSCT using spectratyping
Time frame: 0, 2, 4, 6, 12 and 24 months post HSCT
The CDR3 (complement determining region) of the TCRβ chain is the most variable region of the TCR and is generated by recombination of the variable, diversity and joining region of the DNA. The length of this region differs between different T-cell clones due to nucleotide transferases or removed nucleotides during recombination, and the variability of these lengths can be used to estimate thymic diversity. This variability can be determined by electrophoresis, after amplification of this region by PCR.
Recruiting locations in the United States
Cedars-Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
David Ziring, MD310-423-7100David.Ziring@cshs.org
Yvette Gonzales, MBA310-423-4072Yvette.Gonzales@cshs.org
David Ziring, MD
Shervin Rabizadeh, MD
Ronald Paquette, MD
Central study contacts
Registry dates
- First posted
- Jan 13, 2020
- Primary completion
- Sep 30, 2027
- Overall completion
- Sep 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.