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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves testing a treatment for osteoarthritis in 300 patients with affected knees, hips, and shoulders. The study will measure symptoms like pain and mobility to evaluate the treatment's effectiveness. The goal is to see if the new treatment can improve daily life and joint function for these patients.

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.

What data supports the effectiveness of the treatment AdMSCs for osteoarthritis?

Research shows that adipose-derived mesenchymal stem cells (AdMSCs) can help reduce pain and improve joint function in people with knee osteoarthritis, leading to a better quality of life. Studies in rats also suggest that AdMSCs can reduce inflammation and protect cartilage cells, which are important for joint health. ^{1 2 3 4 5}

How is the treatment AdMSCs for osteoarthritis different from other treatments?

Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) are unique because they are stem cells taken from fat tissue that can help reduce pain and improve joint function in osteoarthritis by reducing inflammation and promoting cell repair, unlike traditional treatments that mainly focus on pain relief. ^{1 2 3 5 6}

Research Team

Derek W Guillory, MD.

Principal Investigator

Root Causes Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Human adipose and synovial mesenchymal stem cells improve osteoarthritis in rats by reducing chondrocyte reactive oxygen species and inhibiting inflammatory response. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The role of adipose-derived mesenchymal stem cells in knee osteoarthritis: a meta-analysis of randomized controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Adipose derived mesenchymal stem cells alleviated osteoarthritis and chondrocyte apoptosis through autophagy inducing. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Current Literature on Treatments Containing Adipose-Derived Stem Cells for Osteoarthritis: a Progress Update. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Safety and efficacy of adipose-derived mesenchymal stem cells for knee osteoarthritis: A systematic review and m-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Mapping global trends in adipose-derived mesenchymal stem cell research: A bibliometric analysis using scopus database. [2023]