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

Non Union/Delayed Fractures Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01435434
• Other study ID #: lieb001-CTIL-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: September 4, 2011
• Last updated: March 3, 2014

Study information

• Verified date: March 2014
• Source: Hadassah Medical Organization
• Contact: Hadas Lemberg, PhD
• Phone: 00 972 2 6777572
• Email: lhadas[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Non Union/Delayed Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and radiological bony union at 3 months and 6 months.