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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
Select...
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

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

Frequently Asked Questions

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

What are the goals that this team of researchers is hoping to achieve?

"The primary outcome for this study, which will be monitored over the course of 12 months, is tracking and assessing the rate of adverse events related to annualized Allogeneic Mesenchymal Stem Cells (AdMSC). Additionally, this trial will measure secondary outcomes such as changes in joint images from baseline levels (using X-rays or MRI), change in Knee Society Score from baseline levels for patients with osteoarthritis in their knees, and change in Knee injury and Osteoarthritis Outcome Score from baseline levels for patients with osteoarthritis in their knees."

Answered by AI

Has the FDA cleared Celltex-derived mesenchymal stem cells for therapeutic use?

"Because there is only data supporting safety and no efficacy, our team has given Celltex- AdMSCs a score of 2."

Answered by AI

Are volunteers still being accepted for this experiment?

"This study is no longer recruiting patients, as indicated on clinicaltrials.gov. This particular trial was first posted on September 25th, 2022 and last updated on May 3rd, 2022; however, there are other 774 studies that are still enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Missouri
How old are they?
65+
18 - 65
What site did they apply to?
Stanley C Jones
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am trying to prolong the need for a shoulder replacement.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
2023. "Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04448106.
All > Scs > Osteoarthritis Knee
~90 spots leftby Aug 2024
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