TGI SVF material via intramuscular injection for Critical Limb Ischemia (CLI-DI Trial)

N/A

Waitlist Available

Research Sponsored by Tissue Genesis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Awards & highlights

CLI-DI Trial Summary

This trial will test whether a device that removes cells from fat tissue can help treat patients with blocked arteries in their legs, which may lead to amputation.

Eligible Conditions

Critical Limb Ischemia

CLI-DI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amputation-Free Survival

CLI-DI Trial Design

1Treatment groups

Experimental Treatment

Group I: Study TreatmentExperimental Treatment1 Intervention

Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation.

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Who is running the clinical trial?

Tissue GenesisLead Sponsor

3 Previous Clinical Trials

150 Total Patients Enrolled

U.S. Army Medical Research and Development CommandFED

285 Previous Clinical Trials

245,139 Total Patients Enrolled

Media Library

Critical Limb Ischemia Research Study Groups: Study Treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research opportunity actively recruiting participants?

"The information found on clinicaltrials.gov suggests that recruitment for this medical trial is not currently ongoing. Initially posted in August of 2014, the trial was last updated June 23rd 2021 and has no current openings; although 405 other trials are actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia

2014. "Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02234778.