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Cartilage Repair
GelrinC for Cartilage Defects (SAGE Trial)
N/A
Waitlist Available
Research Sponsored by Regentis Biomaterials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
Must not have
Presence of an additional grade III or IV symptomatic lesion
Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing GelrinC, a special gel designed to help repair damaged knee cartilage. It targets patients with knee cartilage defects who need effective treatment. The gel works by forming a support structure that helps new cartilage cells grow and repair the damaged area. GelrinC has shown significant improvement in radiological outcomes for treating chondral and osteochondral femoral cartilage lesions.
Who is the study for?
This trial is for adults aged 18-50 with a Body Mass Index (BMI) of 35 or less, who have a specific type of knee cartilage damage (ICRS III or IV) that's no larger than 5 cm2 and not deeper than 5 mm. The other knee must be healthy. People with additional severe lesions, recent bone conditions, untreated ligament issues, recent meniscus surgery, or past failed cartilage treatments can't join.
What is being tested?
The study tests GelrinC against an older method called microfracture in treating knee cartilage defects. It's conducted at multiple centers where patients are openly assigned to either the new treatment arm (GelrinC) or compared to historical data from the control group.
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the injection site, swelling in the treated knee, infection risk due to surgery and possible adverse reactions to GelrinC material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My wound is between 1 and 5 cm2 and no wider than 2.5 cm after cleaning.
Select...
My other knee is healthy and works well without any medical treatment.
Select...
I have a severe knee injury with minimal bone loss.
Select...
I have a severe knee injury with minimal bone loss.
Select...
I am between 18 and 50 years old.
Select...
My other knee is healthy, stable, and hasn't needed medical treatment.
Select...
My wound is between 1 and 5 cm2 after cleaning, no wider than 2.5 cm.
Select...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a severe symptom-causing lesion.
Select...
I have an untreated ACL or PCL injury or my knee is very unstable.
Select...
I have had a previous cartilage repair treatment that did not work.
Select...
I had tendon or ligament surgery in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Microfracture historical control armExperimental Treatment1 Intervention
Microfracture historical control arm
Group II: GelrinC prospective treatment armExperimental Treatment1 Intervention
Patients will undergo GelrinC implantation.
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Who is running the clinical trial?
Regentis BiomaterialsLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My wound is between 1 and 5 cm2 and no wider than 2.5 cm after cleaning.My other knee is healthy and works well without any medical treatment.I have a severe symptom-causing lesion.I had a microfracture surgery less than a year ago.I have an untreated ACL or PCL injury or my knee is very unstable.I have a severe knee injury with minimal bone loss.I have a severe knee injury with minimal bone loss.I was diagnosed with Osteochondritis Dissecans less than a year ago.I have had a previous cartilage repair treatment that did not work.I had tendon or ligament surgery in the last 6 months.I am between 18 and 50 years old.I have not had a recent meniscus surgery or untreated tear.My other knee is healthy, stable, and hasn't needed medical treatment.My wound is between 1 and 5 cm2 after cleaning, no wider than 2.5 cm.I am between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Microfracture historical control arm
- Group 2: GelrinC prospective treatment arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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