EUCTR2010-024162-22-GB进行中（未招募）不适用
A Prospective Open-Label Study to Evaluate the Safety of Cell Bandage (Mesenchymal Stem Cells) in the Treatment of Meniscal Tears - Cell Bandage Phase I Safety Study
Azellon Ltd0 个研究点目标入组 10 人开始时间: 2011年1月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.The subject (or guardian, if appropriate) has signed and dated a specific informed consent form.
- •2. The subject agrees to provide a blood sample for testing of HIV-1, HIV-2, hepatitis B, hepatitis C, and syphilis.
- •3. The subject is between 18 and 35 years of age, inclusive.
- •4. The subject is able to comply with the protocol-defined preoperative procedures, the postoperative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the investigator.
- •5. The subject has a diagnosis of a MRI confirmed (not older than 6 months), irreparable medial meniscus cartilage tear requiring surgical treatment
- •6. The meniscal tear should be a vertical tear in the red/white zone of the meniscus affecting the posterior horn or mid portion of the meniscus
- •7. The subject has no anterior cruciate ligament (ACL) deficiency in the involved knee.
- •8. Haemoglobin >9g/dL and platelet count >100,000/mm3 prior to Day 1
- •9. No contraindication to general anaesthetic
- •10. Female subjects of child-bearing potential: a negative urine pregnancy test
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The subject has a history of total or partial medial or lateral menisectomy in the involved knee.
- •2. The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject’s ability to comply with the recommended rehabilitation program.
- •3. The subject has an ACL deficiency or previous ACL surgery.
- •4. The subject has a diagnosis of untreatable Grade IV (Outerbridge Classification) degenerative cartilage disease in the involved knee joint.
- •5. The subject has an uncorrected malformation or axial malalignment in the involved knee.
- •6. Patients demonstrating an active local or systemic infection (WBC > 15,000/mm3)
- •7. Any condition which in the judgment of the Investigator would preclude adequate evaluation of the CB and clinical outcome.
- •8. The subject has a history of anaphylactoid reaction.
- •9. The subject has an active systemic or local infection.
- •10. The subject has been tested positive for any of the following diseases: HIV (anti-HIV-1 or anti-HIV-2), Hepatitis B (HBs-Ag and anti-Hbc) and Hepatitis C (HCV-Ab), or syphilis (treponema pallidum; not RPR).
- •11. The patient does not wish to know the results of the screening HIV-1, HIV-2, hepatitis B, hepatitis C or syphilis blood tests
- •12. The subject has received systemic administration of any type of corticosteroid, antineoplastic, immunostimulating, or immuno-suppressive agents within 30 days prior to the scheduled bone marrow absorption or surgery.
- •13. The subject has evidence of osteonecrosis of the involved knee.
- •14. The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis.
- •15. If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months
研究者
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