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Cell Therapy

Fat Cell Injection for Knee Osteoarthritis

N/A
Recruiting
Research Sponsored by GID BIO, Inc.
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 1 days
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test a new treatment for osteoarthritis pain that involves injecting fat cells into the knee joint.

Who is the study for?
This trial is for men and women aged 35-85 with knee osteoarthritis who've tried at least two treatments without success, including physical therapy or injections. They must not have had recent major knee injuries, surgery, or certain other joint conditions. Participants need to understand English, be able to attend follow-up visits, and have a BMI between 22 and 37.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a single injection using autologous adipose-derived SVF produced by the GID SVF-2 device system in reducing pain and improving function in patients with knee osteoarthritis.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with injections such as pain at the injection site, infection risk, allergic reactions to components like lidocaine or epinephrine used during the procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ 1 days
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, 1 days for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Western Ontario and McMaster Universities Arthritis Index
Secondary outcome measures
Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stromal Vascular Fraction (SVF)Experimental Treatment1 Intervention
Subjects will receive an injection of Stromal Vascular Fraction in their index knee
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive an injection of Lactated Ringers in their index knee

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

GID BIO, Inc.Lead Sponsor
4 Previous Clinical Trials
64 Total Patients Enrolled
1 Trials studying Osteoarthritis
39 Patients Enrolled for Osteoarthritis
William Cimino, PhDStudy ChairGID BIO

Media Library

Osteoarthritis Clinical Trial 2023: Autologous Adipose-derived Stromal Vascular Fraction Highlights & Side Effects. Trial Name: NCT04440189 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment restricted to those over 20 years of age?

"Based on the specified enrolment requirements, it is necessary for participants to be aged between 35 and 85 years old."

Answered by AI

How many people are participating at the maximum capacity of this trial?

"This trial requires the enrollment of 124 eligible patients. Two locations in North carolina and Ohio, OrthoCarolina Research Institute and Wake Forest University Health Sciences respectively, are amongst the sites that welcome participants."

Answered by AI

Are there currently any enrollment opportunities for this experiment?

"According to the available information on clinicaltrials.gov, this medical study is actively enrolling candidates at present; it was initially posted in October 2020 and last modified in May 2022."

Answered by AI

How many health care facilities are currently conducting this research experiment?

"At present, 10 medical facilities are enrolling patients for this study. Locations range from Charlotte to Columbus and also include other sites across the country. To reduce travel obligation, it is recommended that potential participants select a trial centre near their residence."

Answered by AI

Is registration for this experiment open to new participants?

"To meet the requirements of this experiment, subjects should be between 35 and 85 years old with a diagnosis of knee osteoarthritis. This trial is slated to enroll 124 volunteers."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Louisiana
Other
How old are they?
65+
18 - 65
What site did they apply to?
UC Davis
New Jersey Regenerative Institute
Tulane University
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

I’ve tried 3 other drugs. I've tried everything else. Knees getting worse, can’t climb stairs to get to house.
PatientReceived no prior treatments
I have had intense bi-lateral knee pain for over 20 years. Pain is getting worse.
PatientReceived 2+ prior treatments
I have tried other treatments and they don't work for me anymore. I don't want a TKR!
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long do screening visits last? How long is the screening and do we get compensation? How many injections?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. OrthoCarolina Research Institute: < 24 hours
  2. Tulane University: < 48 hours
  3. New Jersey Regenerative Institute: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
The American Journal of Sports MedicineJournal
Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial
Garza, Jaime R., Richard E. Campbell, Fotios P. Tjoumakaris, Kevin B. Freedman, Lawrence S. Miller, Daniel Santa Maria, and Bradford S. Tucker. 2020. “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546519899923.
The American Journal of Sports MedicineJournal
Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial
Garza, Jaime R., Richard E. Campbell, Fotios P. Tjoumakaris, Kevin B. Freedman, Lawrence S. Miller, Daniel Santa Maria, and Bradford S. Tucker. 2020. “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546519899923.
clinicaltrials.govStudy
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
2020. "Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04440189.
All > Osteoarthritis Knee > Knee Osteoarthritis
~28 spots leftby May 2025
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