BMC2012: Cell Therapy by Autologous BMC for Large Bone Defect Repair

• Sponsor: Goethe University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02803177
• Collaborator: LOEWE CGT (Other)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 42
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

In the present phase-II clinical trial the researchers investigate efficacy and proof of concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.

Condition or Disease	Intervention/Treatment	Phase
Humerus Fracture Displaced Proximal	Biological: BMC2012; Device: beta-TCP Chronos® Synthes	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: BMC2012, Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures - a Randomized, Open, Multicentric Study - Phase IIa
• Actual Study Start Date: Jul 2, 2016
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMC2012 + beta-TCP Chronos® Synthes The large bone defect will be bridged as per clinical standard, filled with a clinically established scaffold (beta-TCP Chronos® Synthes), and loaded with 1.3 x 10E6 BMC/ml TCP per 1 ml beta-TCP in situ.	Biological: BMC2012
Placebo Comparator: beta-TCP Chronos® Synthes The large bone defect will be bridged as per clinical Standard and filled with a clinically established scaffold (beta-TCP Chronos® Synthes).	Device: beta-TCP Chronos® Synthes

Outcome Measures

Primary Outcome Measures

1. Secondary dislocation of fracture [12 weeks]

   Secondary dislocation is diagnosed on plain radiographs, if more than 20° varus collapse of the humeral head fragment in relation to the humeral shaft and / or screw penetration through the humeral head is detected

Secondary Outcome Measures

1. Functional outcome after fixation [12 weeks]

   Functional outcome after fixation will be recorded by the Dash-Score at week 12; assessment of safety: all adverse reactions will be recorded and analyzed.

Other Outcome Measures

1. Concomitant medication [day -1]

   Documentation of concomitant medication

2. Adverse events [day -1]

   Documentation of adverse events

3. Concomitant medication [day 0]

   Documentation of concomitant medication

4. Adverse events [day 0]

   Documentation of adverse events

5. Concomitant medication [week 1]

   Documentation of concomitant medication

6. Adverse events [week 1]

   Documentation of adverse events

7. Concomitant medication [week 6]

   Documentation of concomitant medication

8. Adverse events [week 6]

   Documentation of adverse events

9. Concomitant medication [week 12]

   Documentation of concomitant medication

10. Adverse events [week 12]

    Documentation of adverse events

11. Degree of bony bridging (percent of defect area) in the bone fracture [week 1]

    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis

12. Degree of bony bridging (percent of defect area) in the bone fracture [week 6]

    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis

13. Degree of bony bridging (percent of defect area) in the bone fracture [week 12]

    Analysis of fracture healing by radiologic evaluation, consolidation, necrosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients aged between 50. and 90. years with proximal humerus fractures

• indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):

• 2-, 3- or 4-fragment fracture according to Neer

• dislocation of >10 mm between fragments and/or

• angle of > 45° between fragments and/or

• dislocation of tuberculum majus > 5 mm

• negative pregnancy test of premenopausal women

• signed informed consent for surgery and participation in the clinical trial

Exclusion Criteria:

• contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing

• dislocation fracture

• known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)

• pathologic fractures caused by other underlying diseases

• fracture-induced nerve damage

• tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases

• known hypersensibility against components of the transplant

• participation in a clinical trial during the last 3 months prior to this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt	Frankfurt	Hessen	Germany	60528

Sponsors and Collaborators

• Goethe University
• LOEWE CGT

Investigators

• Principal Investigator: Ingo Marzi, MD Prof., Department of Trauma-, hand- and reconstructive surgery, Goethe University, Frankfurt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ingo Marzi, MD Prof., head physician, Goethe University
• ClinicalTrials.gov Identifier: NCT02803177
• Other Study ID Numbers: BMC2012 Phase IIa
• First Posted: Jun 16, 2016
• Last Update Posted: Jan 14, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Ingo Marzi, MD Prof., head physician, Goethe University: large bone defect; bone marrow-derived mononuclear cells
• Additional relevant MeSH terms: Humeral Fractures

Study Results

No Results Posted as of Jan 14, 2020