TerminatedPhase 1/2

Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.

Stopped: Closed early for business reasons (not safety reasons)

United States36 participantsStarted 2003-10

Plain-language summary

The purpose of this multi-center study is to obtain clinical data to substantiate that Aastrom TRC autologous bone marrow cells will regenerate bone in patients with established (appendicular skeletal) non union fractures, when used with one of the commonly employed commercially available allograft chip matrices.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Leukocytes \>=3000/microliters
✓. Absolute neutrophil count \>=1500/microliters
✓. Platelets \>=100,000/microliters
✓. AST (SGOT)/ALT (SGPT) \<2.5 x institutional limits
✓. Creatinine within normal limits or creatinine clearance calculated)\>=60 mL/min/1.73 square miter with creatinine above institutional normal.

Exclusion criteria

✕. Although not an exclusion criteria, the attending physician shall discuss with the patient the advantages of discontinuing smoking cigarettes and/or cigars during the term of the study including discontinuing the use of pharmacologic adjuvant assistance such as nicotine suppression.
✕. The use or discontinuance of ethanol and/or cigarettes/cigars will be noted in the patient's case report forms.

What they're measuring

The primary endpoint will be the proportion of patients with demonstrated healing, including bone formation, at 12 months (or until completely healed) from surgery.

Trial details

NCT IDNCT00424567

SponsorVericel Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Fracture, Ununited trials