Osteoarthritis, KneePhase 2AdMSCsNCT04448106
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
A Phase 2 study testing Celltex- AdMSCs in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Celltex Therapeutics Corporation at 1 site in United States.
Trial summary
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis Shoulder
- What is being tested?
- Celltex- AdMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 15 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years
- Male or female
- Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
- Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
- Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.
Who cannot join
- Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
- Unwillingness or inability to comply with study procedures
- Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
- Clinically active malignant disease
- Previous thrombotic disorder
- History of known pulmonary embolism or known secondary anti-phospholipid syndrome
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- Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
- Major trauma or surgery within 14 days of study treatment start
- Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
- Alcohol, drug, or medication abuse within one year prior to study treatment start
- Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
- Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
- Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
- History of long-term use of immunosuppressive agents
- Organ transplants in the previous 6 months
- Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanley C Jones
Houston, Texas, 77098
Sally McGahee, BS, 713-590-1000 ext. 147, smcgahee@celltexbank.com
About this study
Official title: Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
- Being tested
- Celltex- AdMSCs
- Keywords
- Autologous Adipose-derived Stem Cells (AdMSCs)
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celltex- AdMSCsBiological
Also called AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 Arm 1 - OA Knee | Experimental | 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. Receives: Biological: Celltex- AdMSCs |
| Phase 2 Arm 2 OA Knee | Active comparator | 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 Receives: Biological: Celltex- AdMSCs |
| Phase 2 Arm 3 - OA Hip | Experimental | 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. Receives: Biological: Celltex- AdMSCs |
| Phase 2 Arm 4 - OA Hip | Active comparator | 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 Receives: Biological: Celltex- AdMSCs |
| Phase 2 Arm 5 - OA Shoulder | Experimental | 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. Receives: Biological: Celltex- AdMSCs |
| Phase 2 Arm 6 - OA Shoulder | Active comparator | 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 Receives: Biological: Celltex- AdMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
safety
Measured: 12 months
Any organ damage or safety concerns determined by SMAC 20 blood test.
Safety
Measured: 12 months
Secondary outcomes (7)
Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
efficacy
Measured: 12 months
Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
efficacy
Measured: 12 months
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
efficacy
Measured: 12 months
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
efficacy
Measured: 12 months
Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
efficacy
Measured: 12 month
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
efficacy
Measured: 12 months
changes in joint images (X-ray or MRI) from the baseline
efficacy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start25 Sep 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek W Guillory, MD., Principal investigator, Root Causes Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448106
- Sponsor's protocol ID
- CTX0020-002
- Acronym
- AdMSCs
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
- ClinicalTrials.gov ID
- NCT04448106
- Acronym / sponsor ID
- AdMSCs / CTX0020-002
- Keywords
- Autologous Adipose-derived Stem Cells (AdMSCs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Celltex Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
| Arm | Type | Receives |
|---|---|---|
| Phase 2 Arm 1 - OA Knee | Experimental | Biological: Celltex- AdMSCs50 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. |
| Phase 2 Arm 2 OA Knee | Active comparator | Biological: Celltex- AdMSCsControl 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 |
| Phase 2 Arm 3 - OA Hip | Experimental | Biological: Celltex- AdMSCs50 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. |
| Phase 2 Arm 4 - OA Hip | Active comparator | Biological: Celltex- AdMSCsControl 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 |
| Phase 2 Arm 5 - OA Shoulder | Experimental | Biological: Celltex- AdMSCs50 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. |
| Phase 2 Arm 6 - OA Shoulder | Active comparator | Biological: Celltex- AdMSCsControl 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years
- Male or female
- Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
- Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
- Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.
Key exclusion criteria (16 listed)
- Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
- Unwillingness or inability to comply with study procedures
- Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
- Clinically active malignant disease
- Previous thrombotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celltex- AdMSCsAlso: AdMSCsAutologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue | Biological | Phase 2 Arm 1 - OA Knee, Phase 2 Arm 2 OA Knee, Phase 2 Arm 3 - OA Hip, Phase 2 Arm 4 - OA Hip, Phase 2 Arm 5 - OA Shoulder, Phase 2 Arm 6 - OA Shoulder |
Primary outcome
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.
Time frame: 12 months
safety
Any organ damage or safety concerns determined by SMAC 20 blood test.
Time frame: 12 months
Safety
7 secondary outcomes
Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
Time frame: 12 months
Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
Time frame: 12 months
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
Time frame: 12 months
Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
Time frame: 12 months
Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
Time frame: 12 month
Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
Time frame: 12 months
changes in joint images (X-ray or MRI) from the baseline
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek W Guillory, MD. principal investigator
Root Causes Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celltex- AdMSCs in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Celltex Therapeutics Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Young (7135901000, jyoung@celltexbank.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.