G-CSF for Promotion of Rotator Cuff Healing

Phase 2

Recruiting

• Conditions: Rotator cuff tear; rotator cuff tear, shoulder; D000070636

• Registration Number: JPRN-jRCTs031220100
• Lead Sponsor: Shitara Hitoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

(1) Between 20 and 65 years old.
(2) Subjects who have a diagnosed with rotator cuff tears.
(3) Subjects whose tears are classified as middle size tears and greater than that by the Cofield's classification.
(4) Subjects who are scheduled to undergo arthroscopic shoulder rotator cuff repair.
(5) Subjects who have given written consent to participate in this study.

Exclusion Criteria

1) Subjects who are hypersensitive to the components of the study drug or other granulocyte colony-forming stimulating factor products.
2) Subjects with myelogenous leukemia in which the number of blasts in the bone marrow is not sufficiently reduced, and research subjects with myelogenous leukemia in which myeloid blasts are observed in the peripheral blood.
3) Subjects with a history of drug hypersensitivity.
4) Subjects with a predisposition to allergy.
5) Subjects who require continuous anticoagulant medication during the perioperative period.
6) Subjects with splenomegaly.
7) Subjects with complications or history of maliglant tumors.
8) Subjects who are pregnant.
9) Subjects who are lactating.
10) Subjects with a history of thrombosis.
11) Subjects with a history of coronary artery disease or cerebrovascular disease.
12) Subjects with cardiac, pulmonary, renal, or hepatic disease requiring treatment.
13) Subjects with abnormal laboratory values requiring treatment or close examination.
14) Subjects with autoimmune diseases.
15) Subjects with neurological diseases.
16) Subjects with uncontrolled hypertension (resting systolic > 160 mmHg or diastolic > 100 mmHg).
17) Subjects with uncontrolled hyperlipidemia (total cholesterol > 240 mg/dL, except for LDL-C < 140 mg/dL).
18) Subjects with diabetes mellitus requiring medication (fasting blood glucose > 125 mg/dL or anytime blood glucose > 200 mg/dL).
19) Subjects with complications or history ofinterstitial pneumonia.
20) Subjects with contraindications to MRI imaging.
21) Other subjects who are judged by a physician to be inappropriate for the subject.

Study & Design

• Study Type: Interventional
• Study Design: Not specified