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

NCT00424567 | Terminated Phase 1

• 1 other identifier: ABI 55-0503-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Fracture, Ununited; Pseudarthrosis

Keywords

Fracture; non union fracture; ununited fracture; pseudarthrosis

Outcome Measures

Primary Outcomes (1)

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

Interventions

Fracture surgery PROCEDURE

Cultured Bone Marrow Tissue DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type IIIA or IIIB fracture
• Fracture gap \< 6 cm.
• Distance of \> 4 cm from joint
• No clinical signs of infection at the wound site or fracture site.
• Adult patients \>18 years of age.
• Male patients or female patients who are not pregnant or lactating.
• Patients must have normal organ and marrow function as defined below:
• 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.
• Patients able to give informed consent

You may not qualify if:

• Other long bone fractures, e.g clavicle
• Patients unable to discontinue ethanol use after surgery including those requiring pharmacologic adjuvant assistance.
• The use or discontinuance of ethanol and/or cigarettes/cigars will be noted in the patient's case report forms.
• Patients who require corticosteroid anti-inflammatory therapy after surgery.
• Patients with genetic metabolic bone disease such as hypophosphatasia, or metabolic bone disorders such as primary or secondary hyperparathyroidism caused by chronic renal insufficiency or other disorders.
• Patients unable to tolerate general anesthesia defined as an ASA criteria of 0 or 1.
• Patients on systemic antibiotics for suspected wound or fracture site infection.
• Patients with diabetes.
• Glasgow score of \< 13.
• Injury severity score of \> 25.
• Allergy to protein products derived from mammalian sources (horse, bovine or porcine) required in the ex-vivo cell production process.

Sponsors & Collaborators

• Vericel Corporation: lead

Study Sites (4)

Illinois Bone and Joint Institute

Des Plaines, Illinois, 60016, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

MeSH Terms

Conditions

Fractures, Ununited; Pseudarthrosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Matthew Jimenez, MD

  Illinosis Bone and Joint Institute

  PRINCIPAL INVESTIGATOR

• James Goulet, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Thomas Lyon, MD

  Lutheran Medical Center

  PRINCIPAL INVESTIGATOR

• Nowinski, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: October 1, 2003
• Study Completion: June 1, 2007
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (4)