Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia

Spinal Cord Neoplasm Clinical Trial

Official title:

Validation of Pre-Clinical Nano-Based Analgesics in Cells From Dorsal Root Ganglia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533919
• Other study ID #: 2020-0526
• Secondary ID: NCI-2020-0524920
• Status: Recruiting
• Start date: June 16, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Andrew J. Shepherd
• Phone: 713-745-7959
• Email: ajshepherd[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). Collecting these neurons may help future research related to safe and effective pain treatment.

Description:

PRIMARY OBJECTIVE:

I. To identify translational mechanisms and therapeutics for neuropathic pain, a type of chronic pain that can arise due to injured nerves.

OUTLINE:

Patients' leftover dorsal root ganglia samples are collected during standard of care surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

---All patients undergoing surgery to resect spinal tumors

Exclusion Criteria:

---None

Related Conditions & MeSH terms

• Spinal Cord Neoplasm
• Spinal Cord Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of dorsal root ganglia

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viability assays	The Viability outcome measure will be expressed using percentage units. This will be calculated as the percentage of cells in culture that are able to exclude a cell permeable dye (Ethidium homodimer) from their nucleus. Entry of this dye into the nucleus and fluorescent binding to nuclear DNA is indicative of a dead/dying cell. Cultured cells that have undergone control or active nanoemulsion treatment in vitro will be loaded with a fluorescent calcium-sensitive dye and continuously monitored while excitation is evoked with a panel of ion channel agonists. The fold-change in intracellular calcium concentration over baseline in response to such excitation is the outcome measure.	3 years
Primary	Functional assays	Neurons will be isolated from fresh tissues and used in assays in which cells are stimulated with pronociceptive chemicals (e.g. agonists for ion channels, pattern recognition receptors, G protein-coupled receptors). Cell activity will be quantified as appropriate (e.g. calcium mobilization). Experimental endpoints will be analyzed using a between-subjects designs to assess differences between patients with and without nerve compression. ANOVA will be performed in a 2 (neuropathic pain vs. control) x 4 (3 treatments vs. control) design. Bonferroni posthoc tests will be applied when significant interactions are found. Age, sex, ethnicity, cancer diagnosis, drug treatments, and history of chronic pain will be included as covariates.	3 years

External Links

•   http://www.mdanderson.org