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Gene Therapy
Gene Therapy for Knee Osteoarthritis (DONATELLO Trial)
Phase 1
Recruiting
Research Sponsored by Genascence Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 1, 3, 6, 12, and 24
Awards & highlights
DONATELLO Trial Summary
This trial will test a gene therapy injection to see if it helps reduce knee pain from osteoarthritis.
Who is the study for?
This trial is for adults with moderate to severe knee osteoarthritis, confirmed by X-ray and pain scores. Participants must have tried at least two conservative treatments without success and be able to provide a synovial fluid sample. Exclusions include recent knee surgery, BMI over 38, significant lab abnormalities, planned surgeries or injections in the next year, inflammatory arthritis history, joint replacement in the target knee, or degeneration from other syndromes.Check my eligibility
What is being tested?
The study tests if a single injection of GNSC-001 gene therapy is safe compared to placebo for those with painful knee osteoarthritis. It explores different dose levels of this AAV gene therapy which aims for transient immune-modulation to alleviate symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include local reactions at the injection site such as pain or swelling, potential allergic responses to components of the therapy and systemic effects related to immune modulation.
DONATELLO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 1, 3, 6, 12, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 1, 3, 6, 12, and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Severity of TEAEs and SAEs
Secondary outcome measures
Change in synovial Interleukin-1 Receptor Antagonist (IL-1Ra) levels over time, from Baseline
Other outcome measures
Immunogenicity of a single dose of GNSC-001
DONATELLO Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: GNSC-001 (low dose) + transient immune-modulation (oral)Experimental Treatment2 Interventions
Group II: GNSC-001 (low dose)Experimental Treatment1 Intervention
Group III: GNSC-001 (high dose) + transient immune-modulation (oral)Experimental Treatment2 Interventions
Group IV: GNSC-001 (high dose) + transient immune-modulation (oral + injectable)Experimental Treatment2 Interventions
Group V: GNSC-001 (high dose)Experimental Treatment1 Intervention
Group VI: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Genascence CorporationLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
64 Previous Clinical Trials
3,092 Total Patients Enrolled
1 Trials studying Osteoarthritis
60 Patients Enrolled for Osteoarthritis
Lachy McLean, MDStudy DirectorGenascence Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had inflammatory arthritis, connective tissue inflammation, or an immune disease.I plan to have surgery or injections in my knee or other joints within a year.I have not had knee surgery in the last 6 months.I have joint issues due to a condition like Ehler's Danlos.My knee arthritis is moderate to severe, confirmed by an X-ray.My knee pain score is 20 or more out of 50.My doctor can likely extract fluid from my joints.My knee pain remains severe despite trying multiple treatments for over 3 months.I have had a partial or total knee replacement.
Research Study Groups:
This trial has the following groups:- Group 1: GNSC-001 (high dose) + transient immune-modulation (oral + injectable)
- Group 2: GNSC-001 (high dose) + transient immune-modulation (oral)
- Group 3: GNSC-001 (low dose) + transient immune-modulation (oral)
- Group 4: GNSC-001 (low dose)
- Group 5: GNSC-001 (high dose)
- Group 6: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research effort still underway?
"According to the details on clinicaltrials.gov, this experiment is searching for volunteers and was initially posted in June 12th 2023 with an alteration made on June 20th of the same year."
Answered by AI
What is the current scope of participation in this research effort?
"Affirmative. The clinical trial, which was first announced on June 12th 2023 has been actively recruiting since then and last updated on the 20th of June. 50 participants are needed at a single medical centre to complete this study."
Answered by AI
Can you elucidate the potential risks of GNSC-001 (high dose) plus transient immune-modulation to those receiving treatment?
"Our team at Power assessed the safety of GNSC-001 (high dose) + transient immune-modulation on a scale from 1 to 3 and determined it was a 1 due to the Phase 1 trial, which has limited data regarding its efficacy and preventative properties."
Answered by AI
Are any applicants under the age of 70 being welcomed into this trial?
"This trial is only open to applicants aged 40-75. For those younger than 18, there are 103 other clinical trials available and for patients over 65 years old there are 1037 applicable medical studies."
Answered by AI
Could I be eligible for inclusion in this clinical research?
"To be accepted into this trial, prospective participants must have arthritis and fall within the defined age range of 40 to 75. This clinical trial is limited to 50 patients in total."
Answered by AI
Who else is applying?
What site did they apply to?
Alliance for Multispecialty Research Kansas City
Biosolutions Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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