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This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Animal models of rotator cuff repair performed by the investigator using murine E-CEL cells in a fibrin carrier vehicle demonstrated increased supraspinatus tendon strength and collagen organization with no observable deleterious side effects compared to surgical repair with the carrier vehicle alone.
After thawing and washing, allogeneic E-CEL UVEC cells will be resuspended in two different solutions; one to deliver the cells under arthroscopic guidance into the supraspinatus tendon repair site and the other to deliver cells into the muscle adjacent to the tendon repair site. Cells delivered to the tendon repair site will be resuspended in human plasma (derived from a peripheral blood sample drawn from the patient), then combined with allogeneic, pharmaceutical grade human thrombin to generate a fibrin matrix, simultaneously with implantation of the cells into the tendon using a two syringes joined with a luer-lock connection under arthroscopic guidance . Cells delivered to the muscle adjacent to the tendon repair site will be resuspended in infusion solution [6.0% Dextran 40 and 10.0% human serum albumin (HSA)], then directly implanted into the muscle.
Full-thickness rotator cuff tears present a clinical challenge, often with occurrence of re-tears after surgical repair and a slow rate of complete functional recovery, which limits daily functional tasks and has negative impacts on qualify-of-life. The frequency of failed healing and re-tear following repair is more pronounced in patients over age 60 due to age-related, intrinsic degenerative changes involving the muscle, tendon, and enthesis.
Currently there is no approved adjunct biological therapy to standard-of- care arthroscopic surgical repair for acceleration of healing, reducing time-to complete functional recovery, and decreasing the rate of re-tear.
Healing of the enthesis, the site of tendon attachment to the bone, can be compromised due to microvascular and vascular niche deficiencies resulting from various causes including aging, prior injuries, and/or tissue degeneration. Administration of exogenous allogeneic engineered CD31+ endothelial cells (E-CEL UVEC® cells) at the surgical repair site of simulated supraspinatus tendon tear in animal models has been shown to positively affect the tissue vascular niche, where tissue regeneration and repair occur, resulting in accelerated healing and a significant improvement in tendon attachment strength at the enthesis repair site.
E-CEL UVEC cells are derived proprietary allogeneic human umbilical vein endothelial cells produced under cGMP and cGTP regulations. The cells are genetically modified by a transduction of Ad5 E4ORF1 gene. The gene has endothelial pro-survival properties. It is found naturally in adenoviruses that have near ubiquitous human exposure.
The non-clinical and CMC information of E-CEL UVEC cells has been reviewed and accepted by the US FDA as part of IND #018355, titled "AB-205-001". Specifically, E-CEL UVEC cells comprise the cellular component of AB-205, an experimental engineered cell therapy, that will be administered intravenously to subjects with relapsed lymphoma after treatment with high dose therapy and autologous stem cell transplant in a clinical trial sponsored by Angiocrine Bioscience, Inc. Pre-clinical information of E-CEL UVEC cells will be provided via cross-reference to Angiocrine's IND in support of this Investigator Initiated Trial.
There is currently no approved adjunct biologic therapy to improve surgical repairs of full rotator cuff tear, enhance post-operative recovery, and decrease the risk of re-tear. Therefore, it is reasonable to study, via an Investigator Initiated Trial, the safety and feasibility of local implantation of E-CEL UVEC cells along with standard-of-care arthroscopic surgical repair of full rotator cuff tears. The E-CEL UVEC cell dose will be much lower than what is needed for systemic application.
Rotator Cuff Tears
Not yet recruiting
Hospital for Special Surgery, New York
Published on BioPortfolio: 2019-08-20T20:17:10-0400
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Compression of the rotator cuff tendons and subacromial bursa between the humeral head and structures that make up the coracoacromial arch and the humeral tuberosities. This condition is associated with subacromial bursitis and rotator cuff (largely supraspinatus) and bicipital tendon inflammation, with or without degenerative changes in the tendon. Pain that is most severe when the arm is abducted in an arc between 40 and 120 degrees, sometimes associated with tears in the rotator cuff, is the chief symptom. (From Jablonski's Dictionary of Syndromes and Eponymic Diseases, 2d ed)
Injuries to the ROTATOR CUFF of the shoulder joint.
Rapidly destructive shoulder joint and bone disease found mainly in elderly, and predominantly in women. It is characterized by SHOULDER PAIN; JOINT INSTABILITY; and the presence of crystalline CALCIUM PHOSPHATES in the SYNOVIAL FLUID. It is associated with ROTATOR CUFF INJURIES.
The musculotendinous sheath formed by the supraspinatus, infraspinatus, subscapularis, and teres minor muscles. These help stabilize the head of the HUMERUS in the glenoid fossa and allow for rotation of the SHOULDER JOINT about its longitudinal axis.
The discharge of substances into the TEARS.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...