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Completed Phase 1 Interventional

A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.

ClinicalTrials.gov ID: NCT01659762

Public ClinicalTrials.gov record NCT01659762. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 11, 2026, 3:47 AM EST

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Official title

A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01659762
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Emory University
Other
Enrollment
16 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2012 (Type not available)
Primary completion
Jul 2015 (Actual)
Completion
Not listed
Last update posted
Oct 17, 2016

Started 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Emory University Atlanta Georgia 30322 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01659762, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 17, 2016 · Synced Nov 11, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01659762 live on ClinicalTrials.gov.

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