NCT01659762

Brief Summary

In this Phase I trial the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a dose escalation phase I study. The investigators intend to test whether the product is clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

August 6, 2012

Last Update Submit

October 13, 2016

Conditions

Crohn's Disease

Keywords

inflammatory bowel diseaseCrohn's disease

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Monitoring for adverse events at time of MSC infusion and in 12 months following

    12 months

Secondary Outcomes (1)

  • Crohn's disease activity Index (CDAI)

    12 months

Study Arms (1)

autologous mesenchymal stromal cells

EXPERIMENTAL
Biological: autologous mesenchymal stromal cell

Interventions

autologous mesenchymal stromal cellBIOLOGICAL
autologous mesenchymal stromal cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18-65 years of age.
  • Patient must have had CD for at least 3 months from the time of initial diagnosis. The diagnosis of CD must have been confirmed by endoscopic and histological evidence.
  • Patients must have active Crohn's disease as defined by a Crohns Disease Activity Index (CDAI) score between \>220 at screening and baseline.
  • Patients should have no need for immediate surgery (i.e. due to obstruction, strictures, active abscess or perforations ).
  • Subjects must be refractory (defined as lack of response for at least 3 months) to immunomodulators (including 6-mercaptopurine and azathioprine and methotrexate) or anti-TNF therapy at present or some point in the course of their disease. Lack of response is defined by failure to reduce the CDAI score by at least 70 points.
  • The following medications will be allowed: mesalamine and prednisone (stable dose for at least 2 weeks prior to enrollment).
  • Subjects on anti TNF therapy will require a minimum of 4 weeks washout period prior to screening.
  • Subjects on non-steroidal analgesics require a minimum of 2 weeks washout period prior to screening
  • If female and of child-bearing age, patient must be non-pregnant, non-breastfeeding, and use adequate contraception;
  • Patient is willing to participate in the study and has signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Dhere T, Copland I, Garcia M, Chiang KY, Chinnadurai R, Prasad M, Galipeau J, Kugathasan S. The safety of autologous and metabolically fit bone marrow mesenchymal stromal cells in medically refractory Crohn's disease - a phase 1 trial with three doses. Aliment Pharmacol Ther. 2016 Sep;44(5):471-81. doi: 10.1111/apt.13717. Epub 2016 Jul 7.

    PMID: 27385373BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Subra Kugathasan, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Tanvi Dhere, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)