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Corticosteroid
MFat vs Corticosteroid Injection for Knee Osteoarthritis (ARISE Trial)
Phase 3
Waitlist Available
Research Sponsored by Lipogems International spa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have both clinical and radiographic findings consistent with osteoarthritis of the knee:
Females of child-bearing potential must have a negative urine pregnancy test performed within 7 days of study enrollment or be postmenopausal (for at least 2 years) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month visit
Awards & highlights
ARISE Trial Summary
This trial tests if a single injection of MFat or corticosteroid can help treat knee Osteoarthritis pain and function.
Who is the study for?
Adults over 18 with knee osteoarthritis (Grade 2-3) who've had pain despite trying physical therapy and NSAIDs for at least 3 months can join. They must be able to attend follow-ups, read English, and not be pregnant or breastfeeding unless postmenopausal or sterilized. Excluded are those with severe obesity, certain knee deformities, autoimmune diseases needing immunosuppressants, allergies to specific drugs used in the trial, uncontrolled diabetes or blood pressure issues, recent injections or surgeries on the knee.Check my eligibility
What is being tested?
The study is testing a single injection treatment for knee osteoarthritis pain and function: one group receives microfragmented adipose tissue (MFat), while another gets a corticosteroid injection. The effectiveness of these treatments will be compared.See study design
What are the potential side effects?
Possible side effects from MFat could include pain at the injection site, swelling, and infection risk. Corticosteroids may cause joint infection, temporary flare of joint pain, skin discoloration around the injection site, allergic reactions or weakening of nearby bones.
ARISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee pain and X-rays show I have osteoarthritis.
Select...
I am not pregnant, have been menopausal for 2+ years, or have had surgery to prevent pregnancy.
ARISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score
WOMAC-C Subscale Score
Secondary outcome measures
Change in Total WOMAC scores
Change in WOMAC-A Pain Sub Score
Change in WOMAC-C Function Sub Score
ARISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Microfragmented Adipose Tissue (Mfat)Experimental Treatment1 Intervention
Injection of Microfragmented Adipose Tissue derived using Lipogems® Kit
The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo lipoaspiration of their own adipose tissue for Mfat then this Mfat will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.
Group II: Corticosteroid InjectionActive Control1 Intervention
The cases assigned to this group will be injected intra-articularly in the knee with a corticosteroid. It will be administered once at the baseline visit of the study.
Find a Location
Who is running the clinical trial?
Lipogems International spaLead Sponsor
3 Previous Clinical Trials
371 Total Patients Enrolled
2 Trials studying Osteoarthritis
291 Patients Enrolled for Osteoarthritis
Alira HealthUNKNOWN
3 Previous Clinical Trials
237 Total Patients Enrolled
1 Trials studying Osteoarthritis
173 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had knee surgery within the last 6 months.I have knee pain due to a specific bone condition, ligament damage, or a severe meniscus tear.I am on prescription pain medication for a condition not related to my knee.I have not had injections in my knee in the last 6 months.You are willing to provide written consent and sign the HIPAA Authorization before taking part in this study.My knee pain and X-rays show I have osteoarthritis.I cannot have fat tissue taken for medical procedures.I have had knee pain for over 3 months that hasn't improved with basic treatments.I do not have any active infections, including in my knee or at any tissue harvest site.I am not willing to stop taking over-the-counter pain meds for 7 days before follow-up visits, except for a daily baby aspirin.I haven't had a severe knee infection or needed antibiotics for any infection in the last 3 months.I have not taken oral steroids in the last 90 days and won't during the study.My blood pressure is high despite taking 3 or more medications.I have tried physical therapy and pain medication for 3 months without relief.My knee arthritis is either very mild or very severe.I have an autoimmune disease and take medication to suppress my immune system.I have been diagnosed with HIV or viral hepatitis.My knee pain is due to moderate arthritis, confirmed by a recent X-ray.I have had an organ or bone marrow transplant.I have a history of stroke or brain blood flow problems.I can come back for several follow-up visits.I cannot stop taking NSAIDs for 7 days before and 2 weeks after an injection, but I can take Tramadol and keep a diary of its use.My knee is significantly bent inward or outward.I have a blood clotting disorder or am on blood thinners.I am not pregnant, have been menopausal for 2+ years, or have had surgery to prevent pregnancy.My knee pain is due to arthritis or another specific condition like osteonecrosis or cancer.I have knee problems but only one knee qualifies for the study based on my pain score.I don't have conditions like back or hip pain that would affect my knee's evaluation.I am expecting to have surgery within the next year.I have not had chemotherapy or radiation on the leg or site planned for fat tissue removal.I injured my knee within the last 6 months.I am willing to stop taking prescription pain or anti-inflammatory meds, except Tramadol.My knee injury is untreated and causes symptoms like locking or catching.I have a history of heart disease.I have asthma symptoms even though I am on medication.I was diagnosed with a non-basal cell cancer in the last 5 years.My prescription medications have not changed in the last month.I have tried physical therapy and pain medication for 3 months without relief.I am 18 years old or older.I experience pain, swelling, stiffness, or limited movement in my joints.
Research Study Groups:
This trial has the following groups:- Group 1: Corticosteroid Injection
- Group 2: Microfragmented Adipose Tissue (Mfat)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05660772 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate the risks associated with Microfragmented Adipose Tissue (Mfat) for individuals?
"Our team's assessment of Microfragmented Adipose Tissue (Mfat) safety yielded a score of 3 due to the prior evidence for efficacy and multiple studies confirming its security."
Answered by AI
Is registration for this trial still in progress?
"This research initiative, which was initially listed on December 20th 2022 and last modified on the thirteenth of that same month, is not recruiting additional patients at this time. Despite this fact, there are still 706 medical studies actively gathering participants across the world."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
New York
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Stanford University
Regenerative Orthopedics and Sports Medicine (ROSM)
Northwell Health
Other
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
Anything I can do to help myself, and others is appealing. Knee pain, for years, getting worse. Do not want surgery.
PatientReceived no prior treatments
I have tried other procedures that didn’t work. Am trying to avoid knee replacement.
PatientReceived 1 prior treatment
The constant pain mostly in my right knee. I enjoy doing clinical trials maybe I can make a difference.
PatientReceived 2+ prior treatments
I've had knee problems for. 20 years. I used to medicate with 30mg oxys. I did injections but I have not done anything in about 20 years and I have chronic pain everyday. Just want to try different things and maybe one day something will work for everyone who has knee pain.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Regenerative Orthopedics and Sports Medicine (ROSM): < 48 hours
Average response time
- < 2 Days
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