Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn'... | NCT02445547

Studies
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

NCT02445547

Sponsor

Fuzhou General Hospital

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

82Actual

Phase

Phase 1Phase 2

Conditions

Crohn Disease

Interventions

UC-MSCs by peripheral intravenous infusion
received hormone maintenance therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Not provided

First Submitted Date

May 13, 2015

First Submission Date that Met QC Criteria

May 14, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
Shaanxi Provincial People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC-MSCs	Experimental	UC-MSCs by peripheral intravenous infusion	Other: UC-MSCs by peripheral intravenous infusion
control	Active Comparator	received hormone maintenance therapy	Drug: received hormone maintenance therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UC-MSCs by peripheral intravenous infusion	Other		UC-MSCs
received hormone maintenance therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crohn's disease activity index		12 months

Secondary Outcomes

Measure	Description	Time Frame
Harvey-Bradshaw index		12 months
Corticosteroid dosage		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 18 years of age
moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
had received hormone maintenance therapy for more than 6 months

Exclusion Criteria:

active tuberculosis
malignancy
HIV
syphilis
hepatitis B
hepatitis C

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaanxi Provincial People's Hospital		XI Ail	Shaanxi	111111	China

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided