Non Traumatic Osteonecrosis of the Femoral Head (Hip)Early Phase 1NCT07787923
Safety, Tolerability, and Preliminary Efficacy of Intra-Articular Injection of Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Non-Traumatic Avascular Necrosis of the Femoral Head
A Early Phase 1 study testing Exosome Intervention Group in people with Non Traumatic Osteonecrosis of the Femoral Head (Hip), run by Beijing Jishuitan Hospital.
Trial summary
This is a first-in-human, single-arm, open-label, dose-escalation, exploratory Phase I clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of local injection of mesenchymal stem cell-derived exosomes for non-traumatic osteonecrosis of the femoral head (ONFH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Traumatic Osteonecrosis of the Femoral Head (Hip)
- What is being tested?
- Exosome Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, inclusive, with no restriction on sex.
- A diagnosis of non-traumatic osteonecrosis of the femoral head (ONFH) confirmed by clinical manifestations and imaging findings, with ARCO stage II or IIIA disease. Patients with advanced femoral head collapse (ARCO stage IIIB or IV) will be excluded.
- The target hip must be treatment-naïve, defined as no prior hip-specific interventional or injection-based treatment for the affected side.
- Ability to understand and voluntarily provide written informed consent, with an expectation of completing long-term follow-up.
Who cannot join
- Presence of an active infection in the target joint (e.g., septic arthritis or infectious osteomyelitis), or skin disruption, infection, or other abnormalities at the intended injection site.
- Receipt of intra-articular injection therapy in the affected hip within 3 months before screening, including corticosteroids or sodium hyaluronate.
- Presence of any active systemic autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or a primary or secondary immunodeficiency disorder.
- History of malignancy.
- Clinically significant abnormal laboratory findings during screening, including impaired hepatic or renal function (ALT or AST >1.5 × the upper limit of normal [ULN], or serum creatinine >ULN), or clinically significant abnormalities on complete blood count.
- Coagulation disorders (PT or APTT >1.5 × ULN), active bleeding risk, or a requirement for long-term anticoagulant therapy that cannot be interrupted.
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- Severe systemic chronic disease not adequately controlled with medication, such as severe heart failure or uncontrolled severe hypertension or diabetes mellitus.
- Severe alcohol dependence or a history of substance or corticosteroid abuse that, in the investigator's judgment, cannot be controlled during the trial and may substantially compromise treatment adherence or efficacy assessment.
- Participation in another clinical trial within 3 months before screening, or previous treatment with stem cells, exosomes, or other cell- or biologic-based therapies.
- Known hypersensitivity to any component of the investigational product.
- Women who are pregnant or breastfeeding, or patients who plan to conceive during the trial or within 6 months after the last administration.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety, Tolerability, and Preliminary Efficacy of Intra-Articular Injection of Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Non-Traumatic Avascular Necrosis of the Femoral Head: A Single-Arm, Open-Label, Dose-Escalation Clinical Trial
This is a first-in-human, single-arm, open-label, dose-escalation, exploratory Phase I clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of local injection of mesenchymal stem cell-derived exosomes for non-traumatic osteonecrosis of the femoral head (ONFH).
A total of 15 treatment-naïve patients with non-traumatic, non-septic ONFH at ARCO stages I-IIIA, treated at the outpatient clinic of our hospital between June 2026 and June 2027, will be enrolled. Under ultrasound guidance, exosomes will be administered via an anterior approach through a single intra-articular injection into the hip joint. Three dose cohorts will be evaluated: \(4 \times 10^{10}\), \(1.2 \times 10^{11}\), and \(3.6 \times 10^{11}\) particles per administration per hip. The low-dose cohort will include 3 patients, while the medium- and high-dose cohorts will each include 6 patients. The dose-limiting toxicity observation period will extend from the first administration to 14 days after the final administration.
Exosomes will be administered once every 2 weeks at a volume of 3 mL per injection. Three administrations will constitute one treatment course, with a total treatment duration of 4 weeks. The primary endpoints are safety outcomes, including the incidence of adverse events, serious adverse events, and dose-limiting toxicities after administration. Secondary exploratory efficacy endpoints include changes in the Visual Analog Scale (VAS) pain score, Harris Hip Score (HHS), and radiological findings of the femoral head. The follow-up period will be 12 months.
- Being tested
- Exosome Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome Intervention GroupBiological
Participants will undergo dose escalation starting from the lowest dose, with sequential dose levels of 4×10*10、1.2×10*11、3.6×10*11particles per administration per hip.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose cohort | Experimental | Not described Receives: Biological: Exosome Intervention Group |
| Middle-dose cohort | Experimental | Not described Receives: Biological: Exosome Intervention Group |
| High-dose cohort | Experimental | Not described Receives: Biological: Exosome Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs)
Measured: Day 1 through Day 43
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), graded by CTCAE v6.0
Measured: Day 1 through Month 12
Number of participants with suspected unexpected serious adverse reactions (SUSARs)
Measured: Day 1 through Month 12
Secondary outcomes (8)
Change from baseline in Visual Analogue Scale (VAS) pain score
The Visual Analogue Scale (VAS) is a 0-to-10-point scale for pain assessment. A score of 0 represents no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 represents severe pain, with 10 defined as the worst imaginable pain.
Measured: Baseline, Month 3, 6, 12
Change from baseline in Harris Hip Score
The Harris Hip Score (HHS) is a clinician-rated 0-to-100-point scale for hip-related function and disability, covering four domains: pain, function, range of motion, and deformity. Higher scores represent better hip performance. Scores of 90-100 are defined as excellent, 80-89 as good, 70-79 as fair, and scores below 70 as poor.
Measured: Baseline, Month 3, 6, 12
Change from baseline in WOMAC score
The WOMAC score is a patient-reported outcome assessing pain, joint stiffness and physical function for hip or knee disorders. It contains 24 items with individual item scores ranging from 0 (none) to 4 (extreme). The total score ranges from 0 to 96, where higher scores indicate more severe symptoms. Total scores 0-24 represent minimal symptoms, 25-41 mild, 42-69 moderate, 70-86 severe, and ≥87 extreme symptoms.
Measured: Baseline, Month 3, 6, 12
Change from baseline in necrotic lesion volume of the femoral head on MRI
Measured: Baseline, Month 6, 12
Change from baseline in bone marrow edema area of the femoral head on MRI
Measured: Baseline, Month 6, 12
Number of participants with stable or improved ARCO stage
Measured: Baseline, Month 6, 12
Number of participants with successful intra-articular injection
Measured: Day 1, 15, 29
Number of participants with local reactions after injection
Measured: Day 1, 15, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Traumatic Osteonecrosis of the Femoral Head (Hip)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Carrier Biomed (Suzhou) Co., Ltd
- Responsible party
- Principal investigator, Deng XiaoLi, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787923
- Sponsor's protocol ID
- K2026369-00
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 28 Aug 2026
- 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Preliminary Efficacy of Intra-Articular Injection of Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Non-Traumatic Avascular Necrosis of the Femoral Head: A Single-Arm, Open-Label, Dose-Escalation Clinical Trial
- ClinicalTrials.gov ID
- NCT07787923
- Acronym / sponsor ID
- K2026369-00
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Carrier Biomed (Suzhou) Co., Ltd
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 26 Aug 2026 (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 first-in-human, single-arm, open-label, dose-escalation, exploratory Phase I clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of local injection of mesenchymal stem cell-derived exosomes for non-traumatic osteonecrosis of the femoral head (ONFH).
A total of 15 treatment-naïve patients with non-traumatic, non-septic ONFH at ARCO stages I-IIIA, treated at the outpatient clinic of our hospital between June 2026 and June 2027, will be enrolled. Under ultrasound guidance, exosomes will be administered via an anterior approach through a single intra-articular injection into the hip joint. Three dose cohorts will be evaluated: \(4 \times 10^{10}\), \(1.2 \times 10^{11}\), and \(3.6 \times 10^{11}\) particles per administration per hip. The low-dose cohort will include 3 patients, while the medium- and high-dose cohorts will each include 6 patients. The dose-limiting toxicity observation period will extend from the first administration to 14 days after the final administration.
Exosomes will be administered once every 2 weeks at a volume of 3 mL per injection. Three administrations will constitute one treatment course, with a total treatment duration of 4 weeks. The primary endpoints are safety outcomes, including the incidence of adverse events, serious adverse events, and dose-limiting toxicities after administration. Secondary exploratory efficacy endpoints include changes in the Visual Analog Scale (VAS) pain score, Harris Hip Score (HHS), and radiological findings of the femoral head. The follow-up period will be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose cohort | Experimental | Biological: Exosome Intervention Group |
| Middle-dose cohort | Experimental | Biological: Exosome Intervention Group |
| High-dose cohort | Experimental | Biological: Exosome Intervention Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years, inclusive, with no restriction on sex.
- A diagnosis of non-traumatic osteonecrosis of the femoral head (ONFH) confirmed by clinical manifestations and imaging findings, with ARCO stage II or IIIA disease. Patients with advanced femoral head collapse (ARCO stage IIIB or IV) will be excluded.
- The target hip must be treatment-naïve, defined as no prior hip-specific interventional or injection-based treatment for the affected side.
- Ability to understand and voluntarily provide written informed consent, with an expectation of completing long-term follow-up.
Key exclusion criteria (11 listed)
- Presence of an active infection in the target joint (e.g., septic arthritis or infectious osteomyelitis), or skin disruption, infection, or other abnormalities at the intended injection site.
- Receipt of intra-articular injection therapy in the affected hip within 3 months before screening, including corticosteroids or sodium hyaluronate.
- Presence of any active systemic autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or a primary or secondary immunodeficiency disorder.
- History of malignancy.
- Clinically significant abnormal laboratory findings during screening, including impaired hepatic or renal function (ALT or AST >1.5 × the upper limit of normal [ULN], or serum creatinine >ULN), or clinically significant abnormalities on complete blood count.
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 |
|---|---|---|
| Exosome Intervention GroupParticipants will undergo dose escalation starting from the lowest dose, with sequential dose levels of 4×10*10、1.2×10*11、3.6×10*11particles per administration per hip. | Biological | High-dose cohort, Low-dose cohort, Middle-dose cohort |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Day 1 through Day 43
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), graded by CTCAE v6.0
Time frame: Day 1 through Month 12
Number of participants with suspected unexpected serious adverse reactions (SUSARs)
Time frame: Day 1 through Month 12
8 secondary outcomes
Change from baseline in Visual Analogue Scale (VAS) pain score
Time frame: Baseline, Month 3, 6, 12
Change from baseline in Harris Hip Score
Time frame: Baseline, Month 3, 6, 12
Change from baseline in WOMAC score
Time frame: Baseline, Month 3, 6, 12
Change from baseline in necrotic lesion volume of the femoral head on MRI
Time frame: Baseline, Month 6, 12
Change from baseline in bone marrow edema area of the femoral head on MRI
Time frame: Baseline, Month 6, 12
Number of participants with stable or improved ARCO stage
Time frame: Baseline, Month 6, 12
Number of participants with successful intra-articular injection
Time frame: Day 1, 15, 29
Number of participants with local reactions after injection
Time frame: Day 1, 15, 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exosome Intervention Group in people with Non Traumatic Osteonecrosis of the Femoral Head (Hip), run by Beijing Jishuitan Hospital.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XIAOLI DENG (010 50963096, dearnesta@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities (DLTs) (time frame: Day 1 through Day 43). The study lists 3 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 28 Aug 2026.