Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00797550
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00797550
Study Brief:
Protocol Section:
NCT00797550