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OpenTrials
Completed

NCT Number: NCT02445547

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shaanxi Provincial People's Hospital

XI Ail, Shaanxi, 111111, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UC-MSCs by peripheral intravenous infusion

Other

received hormone maintenance therapy

Drug

Primary outcomes

  1. Crohn's disease activity index

    Time frame: 12 months

Secondary outcomes

  1. Harvey-Bradshaw index

    Time frame: 12 months

  2. Corticosteroid dosage

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Collaborators

  • Shaanxi Provincial People's Hospital

Registry information

Official study title

Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial

Important dates

Study start
2012
Primary completion
2015
First posted
May 15, 2015
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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