Stem Cell Transplantation in Crohn's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04224558
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 28 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesna — DRUG
    Stem Cell Mobilization: Infused according to institutional guidelines; Post-PBSC Infusion Conditioning: Mesna provided with Cytoxan according to institutional protocol.
  • Cyclophosphamide — DRUG
    Stem Cell Mobilization: Cyclophosphamide (CY) infused intravenously over 1 hour: 50 mg/kg (25 mg/kg/day on 2 consecutive days)
  • Filgrastim — DRUG
    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
  • Apheresis catheter placement — PROCEDURE
    Subjects will require placement of an Apheresis catheter by Intervention Radiologists on the day of collection of stem cells.
  • Leukapheresis — PROCEDURE
    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.
  • Fludarabine — DRUG
    Preparative/Conditioning Regime Fludarabine given as 30 mg/m2 per dose x 4 days, beginning on day -6.
  • Methylprednisolone — DRUG
    Preparative/Conditioning Regime r-ATG pre-medication according to institutional guidelines
  • Diphenhydramine — DRUG
    Preparative/Conditioning Regime r-ATG premedication according to institutional guidelines
  • Acetaminophen — DRUG
    Preparative/Conditioning Regime r-ATG premedication according to institutional guidlines
  • anti-thymocyte globulin (rabbit) — DRUG
    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.
  • lymphocyte immune globulin — DRUG
    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.
  • Peripheral Blood Stem Cell Infusion — BIOLOGICAL
    PBSC (peripheral blood stem cell) infusion on day 0 as per institutional guidelines.
  • Cytoxan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 15, 2019
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Change in mucosal healing [ Time Frame: Change from pre-HSCT (baseline) to 6 months and 12 months post HSCT ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
David Ziring, MD
[email protected]
310-423-7100
Yvette Gonzales, MBA
[email protected]
310-423-4072
David Ziring, MD (PRINCIPAL_INVESTIGATOR)
Shervin Rabizadeh, MD (SUB_INVESTIGATOR)
Ronald Paquette, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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