Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid

Knee Osteoarthritis Clinical Trial

Official title:

Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03710005
• Other study ID #: SLAC-ORTHO-001
• Status: Suspended
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2021
• Source: StimLabs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.

Description:

To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 140
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age greater than 20 years but less than 75 years old

• Both male and female (non-pregnant)

• Valid knee radiograph within 3 months of beginning treatment;

• Diagnosis of OA of the knee

• OA pain in the knee despite conservative measures

• Average daily VAS >= 3

• Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection

• Kellgren-Lawrence system of Grade II, III, or IV

Exclusion Criteria:

• Kellgren-Lawrence Grade I

• Tense effusion of the knee

• Significant valgus/varus deformities

• Viscosupplementation within 6 months

• Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening

• Chronic opioid usage

• History of Leukemia or Lymphoma

• History of any autoimmune disorders and disease

• Immunosuppressive medications

• Active, suspected, or prior infection to the joint

• Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)

• NSAIDs used within 1 week of the procedure

• History of bleeding disorders or inflammatory joint disease

• Patients who plan on becoming pregnant during study period

Related Conditions & MeSH terms

• Dehydration
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Ascent
Dehydrated Cell and Protein Concentrate injection
• Standard
Standard corticosteroid injection

Locations

Country	Name	City	State
United States	Emory Sports Medicine Complex	Brookhaven	Georgia
United States	Emory At Dunwoody	Dunwoody	Georgia
United States	Emory Orthopaedics and Spine Center	Johns Creek	Georgia
United States	Emory at Smyrna	Smyrna	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
StimLabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring changes in quality of life due to treatment, as assessed by patient reported survey.	The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score.	12 months
Secondary	Measured change in pain: VAS	The Visual Analog scale is a patient-reported outcome measure. It will be presented numerically as an 11 point scale that will ask the patient to rate the severity of their pain on a scale form 0 to 10, which 10 being the most pain imaginable and 0 being the least (no pain). The numerical value will be reported based on the patient's response. The mean pain scores of each intervention group will be calculated.	12 months