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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

NCT07787923 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-28

No results posted yet for this study

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).

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.

Conditions

  • Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Interventions

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.

Sponsors & Collaborators

  • Carrier Biomed (Suzhou) Co., Ltd

    collaborator UNKNOWN

  • Beijing Jishuitan Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-05-31
Completion
2028-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787923 on ClinicalTrials.gov