AdMSCs for Osteoarthritis

(AdMSCs Trial)

Overseen By Jane Young

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celltex Therapeutics Corporation

Must not be taking: Immunosuppressants, others

Disqualifiers: Malignant disease, Thrombotic disorder, Organ failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 6 7}

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

I am over 18 years old.

Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures

I have been diagnosed with osteoarthritis in my knees, hips, or shoulders through X-rays and physical exams.

Exclusion Criteria

I have had a blood clotting disorder in the past.

I am not pregnant, breastfeeding, and I am willing to use birth control during the study unless I am surgically sterilized or postmenopausal.

I do not have severe damage to my heart, liver, or kidneys from other diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions and intra-articular injections of AdMSCs over a period of 6 days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: Phase 2 Arm 5 - OA Shoulder Experimental Treatment 1 Intervention

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.

Group II: Phase 2 Arm 3 - OA Hip Experimental Treatment 1 Intervention

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.

Group III: Phase 2 Arm 1 - OA Knee Experimental Treatment 1 Intervention

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.

Group IV: Phase 2 Arm 2 OA Knee Active Control 1 Intervention

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

Group V: Phase 2 Arm 6 - OA Shoulder Active Control 1 Intervention

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

Group VI: Phase 2 Arm 4 - OA Hip Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Celltex Therapeutics Corporation

Lead Sponsor

Trials

5

Recruited

580+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6525553/

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 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003496725042967

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9968820/

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 ...

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-025-04143-6

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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04448106?term=Adipose%20Tissue&intr=stem%20cell&aggFilters=status:not%20rec&page=2&rank=12

Autologous 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- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10785714/

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 ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/03635465231179223

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 ...