A Phase 3 interventional study of Cultured Mesenchymal Stem Cells and Autologous iliac crest graft in Non Union Fracture, sponsored by Universidad Autonoma de Madrid. Completed at 19 sites in 4 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Universidad Autonoma de Madrid · Phase 3, Interventional, and Treatment
ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.
Bone injuries represent an important world medical problem producing significant healthcare and societal expenditure. While most bone injuries are not severe and are capable of healing through bone regeneration by natural callus formation with standard treatments, severe bone injuries may not heal, becoming an important unmet clinical need.
Non-unions, or pseudarthrosis, may occur in 5% to 20% of long-bone fractures that fail to heal properly after more than 6 months, with morbidity, prolonged hospitalization, and increased expenses. The most commonly accepted standard augmentation to procure fracture and non-union healing consists of autologous bone grafting, obtained from the same patient in a different surgical site and transplanted to the reconstruction site. However, autologous bone grafting has some drawbacks (such as persistent pain, scar, late recovery, limited amount of bone, etc) and a limited regeneration efficacy (success rate of about 74%) and high societal cost. Culture-expanded autologous MSCs combined with biphasic calcium phosphate (BCP) biomaterial granules have been claimed as a solid regenerative medicine alternative to autologous bone grafting in non-unions, although current data are limited. In this context, the ORTHOUNION initiative focuses on the opportunity to test the hypothesis of superiority of MSC, the investigational ATMP, versus the currently accepted standard therapy, iliac crest bone autograft to biologically augment surgical treatment of long-bone non-unions.
Exclusion Criteria:
Autologous Cultured Mesenchymal Stem Cells +Biomaterial (Low Dose): 100x106 cells
Biological: Cultured Mesenchymal Stem Cells
Autologous Cultured Mesenchymal Stem Cells+Biomaterial (High Dose): 200x106 cells
Biological: Cultured Mesenchymal Stem Cells
Autologous Iliac Crest Grafting
Procedure: Autologous iliac crest graft
Cultured Mesenchymal Stem Cells obtained from expanded bone marrow
Autologous iliac crest grafting
Bone consolidation
The percentage of bone consolidation in the comparator treatment arm ( iliac crest autograft) and experimental treatment arm (mesenchymal cells).
Time frame: 12 months after treatment
Bone consolidation
To compare bone consolidation between the experimental arms and the comparator
Time frame: 6 and 24 months
Radiological Bone consolidation
To compare bone consolidation, using the REBORNE scale, between the experimental arms and the comparator. The REBORNE scale is an ad-hoc and validated scale, developed by Gomez-Barrena et al. (article currently under preparation) as a modification of the RUST score (Whelan, 2010; Journal of Trauma). In the REBORNE scale, the presence/absence of radiological consolidation is evaluated on a total of 4 cortices. Score range from 0 (no bone callus visible) to 4 (callus present with same density as cortical). The total score will be recorded.
Time frame: 6, 12 and 24 months
Level of Pain
To compare level of pain (by Numeric Rating Scale \[NRS\]) between the experimental arms and the comparator. The NRS is a scale that rates the patient´s pain from 0-10 (0= no pain, 10= worst pain), at the time of the visit.
Time frame: 6, 12 and 24 months
Complications
To compare the rate of complications between the experimental arms and the comparator
Time frame: 6, 12 and 24 months
Health status
To compare the health status (by using the Short Form-36 Health Questionnaire) between treatment arms. The SF-36 questionnaire is a validated, widely used patient-reported health survey which measures their physical and mental health status. It consists of 36 questions organized in 8 dimensions. The total score will be recorded.
Time frame: 6, 12 and 24 months
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Madrid