AdMSCs for Osteoarthritis
(AdMSCs Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment using adipose-derived mesenchymal stem cells, a type of cell therapy, for individuals with osteoarthritis in their knees, hips, or shoulders. The goal is to determine if these stem cells can reduce pain and improve joint function. Participants will either receive the stem cell treatment or join a control group to compare results. Individuals diagnosed with osteoarthritis in these joints and who have stem cells banked at Celltex might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a history of long-term use of immunosuppressive agents or medication abuse, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stem cells taken from fat tissue, known as AdMSCs, have been studied for their safety. One study found that injecting these stem cells directly into the joint was well-tolerated by patients. Most side effects were mild and temporary, such as minor joint pain or swelling at the injection site, while serious side effects were rare.
Another study confirmed these findings, showing that patients who received AdMSCs did not experience any major health problems related to the treatment. The evidence suggests that AdMSCs can be a safe option for those considering participation in clinical trials for osteoarthritis treatments. However, as with any medical treatment, discussing potential risks and benefits with a healthcare provider is important.12345Why are researchers excited about this trial's treatment for osteoarthritis?
Researchers are excited about Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for osteoarthritis because they offer a new approach that stands out from traditional treatments like pain relievers, physical therapy, and corticosteroid injections. Unlike these standard options, AdMSCs work by potentially regenerating damaged tissue, thanks to their unique ability to transform into various cell types and repair cartilage. Additionally, this treatment is delivered directly into the injured joint, which could enhance its effectiveness by targeting the problem area precisely. This innovative approach not only aims to alleviate symptoms but also addresses the underlying damage, offering hope for longer-term relief.
What evidence suggests that this trial's treatments could be effective for osteoarthritis?
Research has shown that stem cells taken from fat tissue, known as Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs), can improve joint function and reduce pain in people with osteoarthritis. In this trial, participants in the experimental arms will receive AdMSCs both through intravenous infusion and direct injection into the joint. One study found that injecting these stem cells directly into the joint provided significant pain relief and improved joint movement. Another study showed that administering AdMSCs through an IV helped people walk better and reduced inflammation, which occurs when the body becomes swollen and painful. These findings suggest that AdMSCs might repair damaged joints by reducing pain and improving joint function.23467
Who Is on the Research Team?
Derek W Guillory, MD.
Principal Investigator
Root Causes Medicine
Are You a Good Fit for This Trial?
This trial is for adults over 18 with osteoarthritis in knees, hips, or shoulders confirmed by X-rays and physical exams. Participants must have their own AdMSCs banked at Celltex, having cleared tests for HIV, syphilis, Hepatitis B and C. They should be able to follow the study procedures and provide informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous infusions and intra-articular injections of AdMSCs over a period of 6 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
Trial Overview
The trial studies the effects of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) on osteoarthritis. It's a phase 2 study with six groups: one control and one treatment group for each joint category (knees, hips, shoulders), assessing pain relief and improved joint function.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Active Control
50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
50 subjects receive two doses of 2.0-2.86 x 10\^6 cells/kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0-2.86 x 10\^6 cells/kg via intra-articular injection into the injured joint.
Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Control group- 50 subjects receive three doses of 2.0-2.86 x 10\^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celltex Therapeutics Corporation
Lead Sponsor
Citations
Intra‐Articular Injection of Autologous Adipose Tissue‐ ...
An intra‐articular injection of autologous adipose tissue‐derived mesenchymal stem cells provided satisfactory functional improvement and pain relief for ...
Effect of intra-articular adipose-derived mesenchymal ...
This study aims to evaluate the efficacy of intra-articular autologous adipose-derived ex vivo expanded mesenchymal stromal cells (ADSC) on ...
Intravenous Injection of Adipose-Derived Mesenchymal ...
Systemic administration of adMSCs by IV injection significantly improved gait parameters and reduced both systemic and intra-articular inflammatory mediators ...
Therapeutic efficacy of intra-articular injection of human ...
These data suggest that the intra-articular injection of haMSCs can effectively repair articular cartilage defects in the knee.
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clinicaltrials.gov
clinicaltrials.gov/study/NCT04448106?term=Adipose%20Tissue&intr=stem%20cell&aggFilters=status:not%20rec&page=2&rank=12Autologous Adipose Tissue-Derived Mesenchymal Stem ...
50 subjects receive two doses of 2.0-2.86 x 10^6 cells /kg on days 0 and 6 via intravenous infusion. On day 3, each subject will receive a single dose of 1.0- ...
Safety and Tolerability of Intra-Articular Injection of Adipose ...
The current study aimed to determine the safety profile of intra-articular-injected allogeneic adipose-derived mesenchymal stem cells ...
Clinical Efficacy and Safety of the Intra-articular Injection ...
Intra-articular injection of autologous adipose tissue-derived mesenchymal stem cells for the treatment of knee osteoarthritis: a phase IIb ...
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