Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003947
• Other study ID #: SC-8-ATG-11-04
• Status: Recruiting
• Phase: Phase 1
• Start date: June 11, 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2022
• Source: The Foundation for Orthopaedics and Regenerative Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of inflammatory bowel disease

Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of inflammatory bowel disease (IBD). Patients with IBD will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of Crohn's disease or Ulcerative Colitis

• Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

• Active infection

• Active cancer

• Chronic multisystem organ failure

• Pregnancy

• Clinically significant Abnormalities on pre-treatment laboratory evaluation

• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.

• Continued drug abuse

• Pre-menopausal women not using contraception

• Previous organ transplant

• Hypersensitivity to sulfur

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations

Country	Name	City	State
Antigua and Barbuda	Medical Surgical Associates Center	St. John's
Argentina	Center for Investigation in Tissue Engineering and Cellular Therapy	Buenos Aires
Mexico	Medyca Bosques	San Pedro Garza García	N.L

Sponsors (1)

Lead Sponsor	Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Countries where clinical trial is conducted

Antigua and Barbuda,  Argentina,  Mexico, 

References & Publications (4)

Hu J, Zhao G, Zhang L, Qiao C, Di A, Gao H, Xu H. Safety and therapeutic effect of mesenchymal stem cell infusion on moderate to severe ulcerative colitis. Exp Ther Med. 2016 Nov;12(5):2983-2989. Epub 2016 Sep 20. — View Citation

Jowett SL, Seal CJ, Barton JR, Welfare MR. The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2921-8. — View Citation

Wilcox AR, Dragnev MC, Darcey CJ, Siegel CA. A new tool to measure the burden of Crohn's disease and its treatment: do patient and physician perceptions match? Inflamm Bowel Dis. 2010 Apr;16(4):645-50. doi: 10.1002/ibd.21094. — View Citation

Zhang J, Lv S, Liu X, Song B, Shi L. Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial. Gut Liver. 2018 Jan 15;12(1):73-78. doi: 10.5009/gnl17035. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events)	Clinical monitoring of possible adverse events or complications	Four year follow-up
Secondary	Efficacy: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	The SIBDQ is a questionnaire to assess the physical, social, emotional, and systemic status for IBD patients. It will be completed for each follow up point.	Four year follow-up