Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures

Hadassah Medical Center

Status: Unknown

Conditions: Non Union/Delayed Fractures

Treatments: Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.

Study type: Interventional

Funder types: Other

Identifiers

NCT01435434

lieb001-CTIL-HMO

Details and patient eligibility

About

The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages: 18 to 65
2. Males- not involved in active military duty.
3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
4. Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.

Exclusion criteria

1. Active systemic or local infection.
2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)
3. Pathological Fractures.
4. Prior Fracture or Prior operation in the current fracture

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

sepax, ignite, fracture healing

Experimental group

Description:

the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT

Treatment:

Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.