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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01435434
First received: September 4, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 .


Condition Intervention
Non Union/Delayed Fractures
Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.

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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • clinical and radiological bony union at 3 months and 6 months.

Arms Assigned Interventions
Experimental: sepax, ignite, fracture healing
the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT
Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435434

Contacts
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Not yet recruiting
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01435434     History of Changes
Other Study ID Numbers: lieb001-CTIL-HMO
Study First Received: September 4, 2011
Last Updated: March 3, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014