Safety, tolerability, pharmacokinetics and bone healing effect of a single dose of Osteogrow (which comprises a protein called BMP6 mixed with the patients own blood to form a clot) in adult patients treated by high tibial wedge osteotomy (HTO) for varus deformity (bow leggedness) of the knee

Phase 1

• Conditions: Osteoarthritis of the medial knee joint compartment and/or symptomatic varus deformity.; MedDRA version: 20.0Level: PTClassification code 10031300Term: OsteotomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2015-001691-21-AT
• Lead Sponsor: Genera Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-18
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients meeting ALL of the following criteria at screening will be eligible for participation in the study:
1.Willing and able to provide informed consent. A signed informed consent form must be provided before any study assessments are done. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written.
2.Male or female, age =18 years. Females of childbearing potential must be using a highly effective method of birth control and must have a negative urine pregnancy test prior to the randomization.
3.Symptomatic varus deformity, assigned for unilateral high tibial opening wedge osteotomy (HTO).
4.Patients not receiving platelet aggregation inhibitors at least 5 days prior to surgery.
5.Patients should be otherwise healthy as defined by absence of clinically relevant abnormalities identified by a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.
6.Willing and able to be confined to the hospital/inpatient unit for at least 5 days postoperatively and to comply with all other follow-up procedures according to the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting ANY of the following criteria at screening will NOT be eligible for participation in the study:
1.Previous osteotomies of the tibia.
2.Inflammatory and neoplastic diseases of the knee joint.
3.Previous treatment with bone morphogenic proteins (e.g. Ossigraft)
4.Evidence or history of clinically significant hepatic disease (>3 x ULN for AST/ALT and total bilirubin) or other abnormalities in screening laboratory tests, which in the judgment of the investigator, would interfere with the patient’s participation in the study.
5.Presence or history of an uncontrolled, unstable, clinically significant medical condition (bone metabolic, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, and malignancy) that in the judgment of the investigator may interfere with the interpretation of safety.
6.Other clinically significant systemic diseases.
7.History of symptomatic nephro- or urolithiasis within two years.
8.Diabetes mellitus.
9.Treatment with an investigational drug within 6 months or 5 half-lives (whichever is longer) preceding the first dose of study medication.
10.Screening 12-lead ECG demonstrating at least 1 of the following: Heart rate >100 bpm, QRS >120 msec, QTc > 430 msec (males), QTc >450 msec (females), or PR interval >220 msec.
11.Positive urine pregnancy test.
12.Breastfeeding a child or planning to become pregnant within 6 months.
13.Use within 7 days prior to surgery and postoperative for the duration of the study of the following medications: NSAIDs (paracetamol accepted) and systemic corticosteroids except for dexamethasone for the first 2 days postoperatively.
14.Known serological evidence of human immunodeficiency virus (HIV) antibody,
15.History of hepatitis B infection within the past year or history of non-adequately treated hepatitis C infection.
16.Patient is a known drug or alcohol abuser.
17.Donation of blood in excess of 500 mL within 56 days prior to and 1 month following surgery.
18. Current participation in any other clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified