Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion

NCT ID: NCT00797550

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-10-31

Brief Summary

The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.

Conditions

Single Level Posterolateral Spinal Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

The Control arm of the study will receive bone autograft.

Group Type: ACTIVE_COMPARATOR

Autologous bone graft

Intervention Type: PROCEDURE

Treatment

The Treatment arm of the study will receive single level posterolateral spinal fusion between L1 to S1 levels with implantation of BRC product.

Group Type: EXPERIMENTAL

Bone Repair Cells (BRCs)

Intervention Type: BIOLOGICAL

BRCs will be administered during spine fusion surgery

Interventions

Bone Repair Cells (BRCs)

BRCs will be administered during spine fusion surgery

Intervention Type: BIOLOGICAL

Autologous bone graft

Intervention Type: PROCEDURE

Other Intervention Names

autologous bone marrow cells

Eligibility Criteria

Inclusion Criteria

• Adults, 18-75 years of age
• Identified as eligible for elective surgery for single (1) level, posterolateral spinal fusion between L1 and S1 in which the spine stabilization is accomplished by pedicle screws and rod.
• Male patients and female patients (not pregnant or lactating). Patients should use an appropriate form of contraception while participating in the study.
• Patients able to give informed consent.
• Normal organ and marrow function

Exclusion Criteria

• Patients with hypophosphatasia, primary or secondary hyperparathyroidism caused by chronic renal insufficiency or osteomalacia.
• Patients with osteoporotic vertebral fractures.
• Patients with a prior spinal fusion at the level to be treated.
• Concomitant use of BMP, or devices containing BMP, or electronic growth stimulators.
• Any active infection of any clinical significance will be excluded from the study.
• Positive for HIV, HTLV and/or syphilis.
• Active Hepatitis B, or Hepatitis C infection at the time of enrollment.
• Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the ex-vivo cell production process.
• Patients who require systemic corticosteroid therapy after surgery.
• Pregnancy or lactation; positive of hCG.
• Body Mass Index (BMI) of 40 Kg/m2 or greater.
• Patients unable to tolerate general anesthesia defined as an ASA criteria of >2.
• Patients with poorly controlled diabetes mellitus (HbA1C >7%).
• Rationale for Exclusion of Certain Study Candidates

1. Patients with other diseases are excluded to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy in posterolateral spine fusion.

2. More extensive surgery requiring more than one (1) level fusion is contraindicated in this study, to avoid confounding factors that might impact evaluation of safety and efficacy of TRC cell therapy.

• In the opinion of the investigator, the patient is unsuitable to cellular therapy or unable to continue with this study.
• Patients that drink more than 2 alcoholic drinks per day or have a history of illicit drug use at the time of enrollment shall not be enrolled in the study.
• Patient known to be non-euthyroid at baseline.
• Patients undergoing active cancer therapy.
• Bisphosphonate Therapy

1. Patients that have undergone bisphosphonate therapy within the last 10 years.

2. Initiation of bisphosphonate therapy in patients during this study is prohibited.

• Patients with a known diagnosis of osteoporosis with recorded BMD less than -2.5.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vericel Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Aastrom Biosciences, Inc.

Principal Investigators

Harry Herkowitz, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Other Identifiers

ABI-55-0509-1

Identifier Type: -

Identifier Source: org_study_id