Autologous Stem Cell Therapy for Fracture Non-union Healing

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Status: Completed

Conditions: Non-union of Fractures

Treatments: Biological: carrier plus in vitro expanded autologous BMSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02177565

RL1 254

Issuing Organisation (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

carrier plus BMSCs

Experimental group

Description:

carrier plus in vitro expanded autologous BMSCs

Treatment:

Biological: carrier plus in vitro expanded autologous BMSCs

carrier alone (control).

Placebo Comparator group

Description:

Carrier alone

Treatment:

Biological: carrier plus in vitro expanded autologous BMSCs