Knee OsteoarthritisPhase 1NCT06463847
Phase I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
A Phase 1 study testing UC-MSCs in people with Knee Osteoarthritis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the "three highs", and poses a continuous threat to China's medical and health system and public health system. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2024to 30 Oct 2026
- Phase
- Phase 1
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to conducting any assessment, written informed consent must be obtained;
- Able to communicate well with researchers during screening, understand and comply with experimental requirements;
- Age range from 50 to 70 years old (including threshold), regardless of gender;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-26 kg/m2 (including critical values);
- According to the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)", subjects diagnosed with knee osteoarthritis (see Annex 1 for details); The course of knee osteoarthritis is more than 4 weeks;
- The target knee joint X-ray Kellgren Lawrence radiological grading (K-L IV grade) is II-III grade. Patients diagnosed with knee osteoarthritis on both sides should have non target knee joint symptoms, signs, and grading that do not exceed the target knee joint;
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- MRI examination shows partial or full layer damage to the cartilage of the knee joint;
- A VAS score of ≥ 5 and ≤ 7 for knee joint pain at least 48 hours after discontinuing the use of all painkillers during screening;
- Patients who use analgesic therapy (taking paracetamol/acetaminophen) to control local pain in the target knee joint agree to discontinue the use of similar analgesics 2 weeks prior to administration, and only allow NSAID as a rescue drug; Patients who use glucosamine, chondroitin, opioid drugs, or diacetate, glucosamine, etc. must agree to discontinue such drugs from 2 weeks prior to administration.
Who cannot join
- Individuals with a history of knee joint infection, surgery, and radiation therapy within 6 months prior to administration;
- Combined instability of the knee joint (anterior and posterior cruciate ligaments, medial and lateral collateral ligaments), rupture, relaxation, or external deformity of the knee joint;
- According to researchers, diseases that may interfere with knee joint function assessment, such as symptomatic lower back pain, lumbar disc herniation, and hip joint pain in the target knee joint;
- According to the judgment of researchers, local diseases that may confuse knee joint function assessment include but are not limited to septic arthritis, reactive arthritis, clinically recurrent pseudogout, chondrocalcinosis, or joint fractures;
- Within 3 months prior to administration, any medication injection treatment (including intra-articular injection of growth factors, hormones, or sodium hyaluronate) or lavage surgery has been received in the knee joint (target side) cavity;
- Merge intra-articular or periarticular tumors (such as knee synovial chondroma, pigmented nodular synovitis, etc.);
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- Various serious systemic diseases such as neurological disorders, respiratory disorders, heart diseases (NYHA grade III and above), and liver dysfunction (ALT>3) × ULN or AST>3 × ULN, renal dysfunction (Cr>2) × ULN or BUN>2 × ULN, coagulation dysfunction (INR>1.5), or severe hematological disorders (such as grade 3 or above anemia, hemoglobin (Hb)<8 g/dL, grade 2 or above thrombocytopenia, PLT<75) × 10 ^ 9/L);
- Diagnosed as systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus, or other systemic diseases that may confuse KOA assessment (such as fibromyalgia);
- Subjects who receive long-term (>14 days) oral corticosteroids>5 mg/day within 3 months prior to administration, or who require long-term glucocorticoid treatment during the trial period;
- Previously received stem cell therapy;
- Uncontrolled hypertension is defined as systolic blood pressure (SBP)>160 mmHg or diastolic blood pressure (DBP)>100 mmHg during screening;
- Having a history of tumors, mental illness, severe autoimmune diseases, hematological diseases, and long-term use of immunosuppressants;
- Have a history of alcohol and prohibited drug abuse;
- Has a history of hypersensitivity to protein drugs;
- There are contraindications to MRI examination or unwillingness to undergo MRI examination;
- Hepatitis B, hepatitis C, AIDS, syphilis serological test positive pathogens;
- Pregnant or lactating women, or male or female patients who tested positive for blood pregnancy during screening or have planned childbirth within 3 months after medication;
- Patients who have received live vaccines or attenuated live vaccines within one month before administration;
- Patients who have participated in clinical trials of other drugs or devices within 3 months prior to administration;
- Patients with poor compliance, poor communication skills, inability to adhere to follow-up, and inability to complete the entire trial;
- The researchers believe that it is not suitable for participants to enter this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
Hongtao Tian, doctor, 18627171618, tianhongtao@vip.163.com
About this study
Official title: Single Center, Open-label, Dose-increasing Phase I Clinical Trial of UC-MSCs for the Treatment of Knee Osteoarthritis
In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the "three highs", and poses a continuous threat to China's medical and health system and public health system. Knee osteoarthritis is the main type of osteoarthritis, ranking 11th in global disability diseases and 38th in disability adjusted life year loss, causing significant economic burden to patients, families, and society. At present, most of the treatment methods for KOA have limited efficacy, only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints. Due to the limitations of adverse events, there is still no optimal treatment plan for KOA. Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects. Given that there is currently no optimal treatment plan for KOA, human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients.
Read the detailed description
Osteoarthritis (OA) is a chronic inflammatory disease of the bone and joints, characterized by degenerative destruction of articular cartilage, subchondral bone sclerosis and osteophyte formation, and peripheral soft tissue inflammation and proliferation. Knee Osteoarthritis (KOA), which is negative and highly active, is the most common. Currently, there are approximately 1 billion KOA patients worldwide, with approximately 150 million patients in China, and the incidence rate increases with age. The clinical manifestation of KOA is repeated and prolonged bone and joint pain, which seriously affects the patient's quality of life, ultimately leading to joint structural damage and loss of function, causing a significant burden on individuals, families, and society. At present, there is a lack of effective treatment methods for KOA both domestically and internationally, and there is an urgent need to research new treatment strategies to meet clinical needs. Numerous studies have shown that local inflammation of the joint cavity and apoptosis of articular chondrocytes are the main pathological mechanisms of knee osteoarthritis. Therefore, the key to treating KOA is to inhibit the local inflammatory response of bone joints, promote chondrocyte regeneration, repair damaged joint surfaces, and restore their normal structure and function.
Mesenchymal Stem Cells (MSCs) are the most widely studied pluripotent stem cells. It exists in various tissues, has multidirectional differentiation potential, homing effect and powerful paracrine function, can regulate tissue microenvironment, promote damaged tissue repair through cell replacement, promote in-situ cell regeneration, anti-inflammatory and immune regulation and other mechanisms. Therefore, mesenchymal stem cell therapy has become the focus of KOA new therapy research. A large number of studies have shown that MSCs can be induced to differentiate into stable mature chondrocytes that can express proteoglycan and type II collagen. Fluorescently labeled MSCs could still be detected 10 weeks after injection into the joint cavity of osteoarthritis model animals, suggesting that MSCs homed in the injured articular cartilage tissue and participated in the regeneration and repair of the injured tissue. The effectiveness of MSCs therapy for KOA has been demonstrated in osteoarthritis models in different animals including rats, rabbits, sheep, pigs, and monkeys. MSCs from different sources can effectively inhibit the inflammatory response and chondrocyte injury in model animals, and stimulate the regeneration and repair of injured chondrocytes.
In this study, three dose groups are preset, which are low-dose group: 5×10^6 cells/2.5mL; medium-dose group: 1×10^7 cells/2.5mL; high-dose group: 2×10^7cells/2.5mL, 9 to 18 subjects will be recruited, and will be sequential from the low-dose group to the high-dose group according to the "3+3" dose escalation principle. At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration. After the last subject in each dose group completes the DLT observation period, the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group, and only after the safe tolerance is determined can the subjects enter the next dose group, so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis. Recommend appropriate cell therapy dose (RP2D) for Phase II clinical trials.
- Conditions
- Knee Osteoarthritis
- Being tested
- UC-MSCs
- Keywords
- Knee Osteoarthritis, UC-MSCs, Cell Therapy, Safety, DLT, Efficiency
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsDrug
In this study, three dose groups are preset, which are low-dose group: 5×10^6 cells/2.5mL; medium-dose group: 1×10^7 cells/2.5mL; high-dose group: 2×10^7cells/2.5mL, 9 to 18 subjects will be recruited, and will be sequential from the low-dose group to the high-dose group according to the "3+3" dose escalation principle. At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration. After the last subject in each dose group completes the DLT observation period, the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group, and only after the safe tolerance is determined can the subjects enter the next dose group, so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis. Recommend appropriate cell therapy dose (RP2D) for Phase II clinical trials.
| Study group | Role | What they receive |
|---|---|---|
| 1UC-MSCs Treatment Group | Experimental | Participants will receive conventional treatment plus 1 time of UC-MSCs (5×10^6 UC-MSCs/2.5mL, single injection into the knee cavity). Receives: Drug: UC-MSCs |
| 2UC-MSCs Treatment Group | Experimental | Participants will receive conventional treatment plus 1 time of UC-MSCs (1×10^7 UC-MSCs/2.5mL, single injection into the knee cavity). Receives: Drug: UC-MSCs |
| 3UC-MSCs Treatment Group | Experimental | Participants will receive conventional treatment plus 1 time of UC-MSCs (2×10^7 UC-MSCs/2.5mL, single injection into the knee cavity). Receives: Drug: UC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence and severity of adverse events after administration (CTCAE 5.0)
Measured: From Baseline (0 W) to 4 weeks after treatment
Secondary outcomes (5)
WOMAC (Western Ontario and McMaster Universities Arthritis Index，with the minimum value 0, and the maximum value 240, and higher scores mean a worse outcome)
Changes in WOMAC score from baseline
Measured: From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment
VAS (Visual Analogue Scale,with the minimum value 0, and the maximum value 10, and higher scores mean a worse outcome)
Changes in VAS score from baseline
Measured: From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment
Changes in knee joint range of motion from baseline
Changes in knee joint range of motion from baseline
Measured: From Baseline (0 W) to 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment]
Changes in X-Kellgren-Lawrence grading and minimum joint space width (mJSW) from baseline
Changes in X-Kellgren-Lawrence grading and minimum joint space width (mJSW) from baseline
Measured: From Baseline (0 W) to 24 weeks, 48 weeks after treatment
Changes of MRI-Roberts cartilage repair score, cartilage thickness and synovial inflammation score (reference MOAKS) compared with baseline
MRI-Roberts score includes cartilage repair score, cartilage thickness and synovial inflammation score，with different grades according to the situation，and the higher grades mean a worse situation (reference MOAKS（Magnetic Resonance imaging Osteoarthritis Knee Score），but not all indicators of MOAKS are included)
Measured: From Baseline (0 W) to 24 weeks, 48 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd., Guangzhou Hamilton Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463847
- Sponsor's protocol ID
- UHCT240051
- Status last verified
- Sep 2023
- First submitted
- 22 Apr 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open-label, Dose-increasing Phase I Clinical Trial of UC-MSCs for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06463847
- Acronym / sponsor ID
- UHCT240051
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, UC-MSCs, Cell Therapy, Safety, DLT, Efficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd., Guangzhou Hamilton Biotechnology Co., Ltd.
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Jun 2024 (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.
In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the "three highs", and poses a continuous threat to China's medical and health system and public health system. Knee osteoarthritis is the main type of osteoarthritis, ranking 11th in global disability diseases and 38th in disability adjusted life year loss, causing significant economic burden to patients, families, and society. At present, most of the treatment methods for KOA have limited efficacy, only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints. Due to the limitations of adverse events, there is still no optimal treatment plan for KOA. Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects. Given that there is currently no optimal treatment plan for KOA, human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients.
Detailed description
Osteoarthritis (OA) is a chronic inflammatory disease of the bone and joints, characterized by degenerative destruction of articular cartilage, subchondral bone sclerosis and osteophyte formation, and peripheral soft tissue inflammation and proliferation. Knee Osteoarthritis (KOA), which is negative and highly active, is the most common. Currently, there are approximately 1 billion KOA patients worldwide, with approximately 150 million patients in China, and the incidence rate increases with age. The clinical manifestation of KOA is repeated and prolonged bone and joint pain, which seriously affects the patient's quality of life, ultimately leading to joint structural damage and loss of function, causing a significant burden on individuals, families, and society. At present, there is a lack of effective treatment methods for KOA both domestically and internationally, and there is an urgent need to research new treatment strategies to meet clinical needs. Numerous studies have shown that local inflammation of the joint cavity and apoptosis of articular chondrocytes are the main pathological mechanisms of knee osteoarthritis. Therefore, the key to treating KOA is to inhibit the local inflammatory response of bone joints, promote chondrocyte regeneration, repair damaged joint surfaces, and restore their normal structure and function.
Mesenchymal Stem Cells (MSCs) are the most widely studied pluripotent stem cells. It exists in various tissues, has multidirectional differentiation potential, homing effect and powerful paracrine function, can regulate tissue microenvironment, promote damaged tissue repair through cell replacement, promote in-situ cell regeneration, anti-inflammatory and immune regulation and other mechanisms. Therefore, mesenchymal stem cell therapy has become the focus of KOA new therapy research. A large number of studies have shown that MSCs can be induced to differentiate into stable mature chondrocytes that can express proteoglycan and type II collagen. Fluorescently labeled MSCs could still be detected 10 weeks after injection into the joint cavity of osteoarthritis model animals, suggesting that MSCs homed in the injured articular cartilage tissue and participated in the regeneration and repair of the injured tissue. The effectiveness of MSCs therapy for KOA has been demonstrated in osteoarthritis models in different animals including rats, rabbits, sheep, pigs, and monkeys. MSCs from different sources can effectively inhibit the inflammatory response and chondrocyte injury in model animals, and stimulate the regeneration and repair of injured chondrocytes.
In this study, three dose groups are preset, which are low-dose group: 5×10^6 cells/2.5mL; medium-dose group: 1×10^7 cells/2.5mL; high-dose group: 2×10^7cells/2.5mL, 9 to 18 subjects will be recruited, and will be sequential from the low-dose group to the high-dose group according to the "3+3" dose escalation principle. At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration. After the last subject in each dose group completes the DLT observation period, the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group, and only after the safe tolerance is determined can the subjects enter the next dose group, so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis. Recommend appropriate cell therapy dose (RP2D) for Phase II clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1UC-MSCs Treatment Group | Experimental | Drug: UC-MSCsParticipants will receive conventional treatment plus 1 time of UC-MSCs (5×10^6 UC-MSCs/2.5mL, single injection into the knee cavity). |
| 2UC-MSCs Treatment Group | Experimental | Drug: UC-MSCsParticipants will receive conventional treatment plus 1 time of UC-MSCs (1×10^7 UC-MSCs/2.5mL, single injection into the knee cavity). |
| 3UC-MSCs Treatment Group | Experimental | Drug: UC-MSCsParticipants will receive conventional treatment plus 1 time of UC-MSCs (2×10^7 UC-MSCs/2.5mL, single injection into the knee cavity). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Prior to conducting any assessment, written informed consent must be obtained;
- Able to communicate well with researchers during screening, understand and comply with experimental requirements;
- Age range from 50 to 70 years old (including threshold), regardless of gender;
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-26 kg/m2 (including critical values);
- According to the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)", subjects diagnosed with knee osteoarthritis (see Annex 1 for details); The course of knee osteoarthritis is more than 4 weeks;
Key exclusion criteria (21 listed)
- Individuals with a history of knee joint infection, surgery, and radiation therapy within 6 months prior to administration;
- Combined instability of the knee joint (anterior and posterior cruciate ligaments, medial and lateral collateral ligaments), rupture, relaxation, or external deformity of the knee joint;
- According to researchers, diseases that may interfere with knee joint function assessment, such as symptomatic lower back pain, lumbar disc herniation, and hip joint pain in the target knee joint;
- According to the judgment of researchers, local diseases that may confuse knee joint function assessment include but are not limited to septic arthritis, reactive arthritis, clinically recurrent pseudogout, chondrocalcinosis, or joint fractures;
- Within 3 months prior to administration, any medication injection treatment (including intra-articular injection of growth factors, hormones, or sodium hyaluronate) or lavage surgery has been received in the knee joint (target side) cavity;
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 |
|---|---|---|
| UC-MSCsIn this study, three dose groups are preset, which are low-dose group: 5×10^6 cells/2.5mL; medium-dose group: 1×10^7 cells/2.5mL; high-dose group: 2×10^7cells/2.5mL, 9 to 18 subjects will be recruited, and will be sequential from the low-dose group to the high-dose group according to the "3+3" dose escalation principle. At least 3 subjects are enrolled in each group for the safety and tolerability test of single administration. After the last subject in each dose group completes the DLT observation period, the sponsor and the researcher jointly confirm the safety tolerance of the subjects in the previous dose group, and only after the safe tolerance is determined can the subjects enter the next dose group, so as to evaluate the safety and tolerance of human umbilical cord mesenchymal stem cell injection in the treatment of knee osteoarthritis. Recommend appropriate cell therapy dose (RP2D) for Phase II clinical trials. | Drug | 1UC-MSCs Treatment Group, 2UC-MSCs Treatment Group, 3UC-MSCs Treatment Group |
Primary outcome
Adverse Events
Time frame: From Baseline (0 W) to 4 weeks after treatment
Incidence and severity of adverse events after administration (CTCAE 5.0)
5 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Arthritis Index，with the minimum value 0, and the maximum value 240, and higher scores mean a worse outcome)
Time frame: From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment
VAS (Visual Analogue Scale,with the minimum value 0, and the maximum value 10, and higher scores mean a worse outcome)
Time frame: From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment
Changes in knee joint range of motion from baseline
Time frame: From Baseline (0 W) to 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment]
Changes in X-Kellgren-Lawrence grading and minimum joint space width (mJSW) from baseline
Time frame: From Baseline (0 W) to 24 weeks, 48 weeks after treatment
Changes of MRI-Roberts cartilage repair score, cartilage thickness and synovial inflammation score (reference MOAKS) compared with baseline
Time frame: From Baseline (0 W) to 24 weeks, 48 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UC-MSCs in people with Knee Osteoarthritis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 9 inclusion and 21 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 1 Jul 2024. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hongtao Tian, MD (18627171618, tianhongtao@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Baseline (0 W) to 4 weeks after treatment). 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 1 Jul 2024.