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A phase II, national, multicenter, uncontrolled and open trial to evaluate the feasibility and safety of lamparoscopic administration of allogenic mesenchymals stem cell (adMSC) extracted by lipoaspirate from healthy patients, for the treatment of patients with inflammatory bowel strictures associated with Crohn's disease. SM

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507108-30-00
Acronym
FJD-MEIC-21-01
Enrollment
20
Registered
2023-07-28
Start date
2022-10-22
Completion date
2024-12-13
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Brief summary

proportion and type of complications arising from treatment (adverse reactions) Complications during anesthesia, Complications arising from the treatment administration procedure

Detailed description

To evaluate the change in the length of the stenosis with respect to the basal in the enteroresonance., To evaluate the change in the CDAI questionnaire score from baseline at 6, 12, 18, 24, 36 and 52 weeks., To assess the change in score from baseline on the IBDQ32 questionnaire at 6, 12, 18, 24, 24, 36 and 52 weeks after treatment, Describe the number of patients with obstructive episode who required resection surgery during the study period.

Interventions

DRUGALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED

Sponsors

Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
proportion and type of complications arising from treatment (adverse reactions) Complications during anesthesia, Complications arising from the treatment administration procedure—

Secondary

MeasureTime frame
To evaluate the change in the length of the stenosis with respect to the basal in the enteroresonance., To evaluate the change in the CDAI questionnaire score from baseline at 6, 12, 18, 24, 36 and 52 weeks., To assess the change in score from baseline on the IBDQ32 questionnaire at 6, 12, 18, 24, 24, 36 and 52 weeks after treatment, Describe the number of patients with obstructive episode who required resection surgery during the study period.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026