Study Stopped
FDA upregulation of dCPC.
Efficacy of Dehydrated Cell and Protein Concentrate Versus Corticosteroid
Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
1 other identifier
interventional
51
1 country
4
Brief Summary
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Oct 2018
Typical duration for not_applicable knee-osteoarthritis
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedJuly 1, 2024
June 1, 2024
2.6 years
October 12, 2018
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Measured change in pain: VAS
12 months
Study Arms (2)
Ascent Intervention Treatment
EXPERIMENTALInterventional treatment arm will receive Ascent dehydrated cell and protein concentrate injection
Standard Treatment
ACTIVE COMPARATORStandard treatment arm will receive a standard Corticosteroid injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StimLabslead
Study Sites (4)
Emory Sports Medicine Complex
Brookhaven, Georgia, 30329, United States
Emory At Dunwoody
Dunwoody, Georgia, 30338, United States
Emory Orthopaedics and Spine Center
Johns Creek, Georgia, 30097, United States
Emory at Smyrna
Smyrna, Georgia, 30080, United States
Related Publications (1)
Olufade O, Negron G, Berrigan W, Sirutis B, Whitley J, Easley K, Chen Y, Mautner K. Amniotic dehydrated cell and protein concentrate versus corticosteroid in knee osteoarthritis: preliminary findings. Regen Med. 2022 Jul;17(7):431-443. doi: 10.2217/rme-2022-0005. Epub 2022 May 19.
PMID: 35586982DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oluseun Olufade, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2018
First Posted
October 17, 2018
Study Start
October 22, 2018
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
July 1, 2024
Record last verified: 2024-06