Autologous Stem Cell Therapy for Fracture Non-union Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2011-10-31

Brief Summary

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Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

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Detailed Description

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Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.

Conditions

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Non-union of Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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carrier plus BMSCs

carrier plus in vitro expanded autologous BMSCs

Group Type EXPERIMENTAL

carrier plus in vitro expanded autologous BMSCs

Intervention Type BIOLOGICAL

The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

carrier alone (control).

Carrier alone

Group Type PLACEBO_COMPARATOR

carrier plus in vitro expanded autologous BMSCs

Intervention Type BIOLOGICAL

The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

Interventions

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carrier plus in vitro expanded autologous BMSCs

The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* An established non-union according to the US Food \& Drug Administration criteria14.
* Non-union following fracture of tibia or femur suitable for synthetic bone grafting.

Exclusion Criteria

1. Skeletal immaturity.
2. Pregnant or breast-feeding.
3. Non-union following pathological fractures.
4. Positive to Hepatitis B, Hepatitis-C or HIV.
5. Infection during BMSC culture.

Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No