CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Aastrom BRCs +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00980278
NCT00980278Phase 2Completed

Cell Therapy Using Autologous Bone Marrow Cells Expanded Ex Vivo and Delivered Using Tricalcium Phosphate

University of Michigan·interventional·Posted Sep 21, 2009·Updated Dec 23, 2015

In Brief

A Phase 2 clinical trial evaluating Sinus lift augmentation and dental implant and Aastrom BRCs for Tooth Loss. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this research is to determine if one's own bone marrow tissue can help regenerate (grow) bone in the area of the jaw where an implant will be placed. The name of the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be collected and sent to a laboratory where it will be processed to form more cells. These new cells will then be transplanted in the regenerative site or sinus floor augmentation site. The researchers are testing to see if these cells (BRC) will help form bone indicating. The research will also determine if the implant will be more stable in the area with new bone growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTooth Loss
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2009
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.8 years ago

Interventions

Sinus lift augmentation and dental implantprocedure

transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.

Aastrom BRCsbiological

sinus augmentation, BRC application, dental implant