An Early Phase 1 interventional study of Exosome Intervention Group in Non Traumatic Osteonecrosis of the Femoral Head (Hip), sponsored by Beijing Jishuitan Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Beijing Jishuitan Hospital · Early Phase 1, Interventional, and Treatment
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 15 is below the median of 68 across 151 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Beijing Jishuitan Hospital is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Exosome Intervention Group
Biological: Exosome Intervention Group
Biological: Exosome Intervention Group
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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Beijing Jishuitan Hospital