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Mesenchymal Stem Cells

AdMSCs for Osteoarthritis (AdMSCs Trial)

Phase 2
Waitlist Available
Led By Derek W Guillory, MD.
Research Sponsored by Celltex Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age above 18 years
Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

AdMSCs Trial Summary

This trial is testing a new arthritis drug on 300 people with osteoarthritis in their knees, hips, or shoulders. The subjects will be evaluated for disease severity using established measurement tools.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions related to stem cell therapy such as inflammation at injection site or allergic reactions to culture components like BSA or DMSO used in AdMSC preparation.

AdMSCs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I have been diagnosed with osteoarthritis in my knees, hips, or shoulders through X-rays and physical exams.

AdMSCs Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Any organ damage or safety concerns determined by SMAC 20 blood test.
the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.
Secondary outcome measures
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
+4 more
Other outcome measures
Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline
Pain

AdMSCs Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Arm 5 - OA ShoulderExperimental Treatment1 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 HipExperimental Treatment1 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 KneeExperimental Treatment1 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 KneeActive Control1 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 ShoulderActive Control1 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 HipActive Control1 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing inflammation and pain. Glucocorticoids, such as prednisone, decrease inflammation by suppressing the immune response. Platelet-rich plasma (PRP) therapy aims to promote tissue repair by injecting concentrated platelets, although its efficacy is still under investigation. Gene therapy approaches, like TissueGene-C, involve modifying cells to produce growth factors that may help in cartilage repair. Understanding these mechanisms helps OA patients and their doctors choose the most appropriate treatment based on the specific pathways involved in their symptoms and disease progression.
Osteoarthritis of the knee - biochemical aspect of applied therapies: a review.

Find a Location

Who is running the clinical trial?

Celltex Therapeutics CorporationLead Sponsor
4 Previous Clinical Trials
284 Total Patients Enrolled
Derek W Guillory, MD.Principal InvestigatorRoot Causes Medicine
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Osteoarthritis Research Study Groups: Phase 2 Arm 3 - OA Hip, Phase 2 Arm 2 OA Knee, Phase 2 Arm 6 - OA Shoulder, Phase 2 Arm 1 - OA Knee, Phase 2 Arm 4 - OA Hip, Phase 2 Arm 5 - OA Shoulder
~30 spots leftby Aug 2024
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