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of cBMA aspirate into the index leg · 1 trial · 3 indications
Safety will be evaluated by review of treatment related AEs during the 12-month follow-up period. The study will be terminated in the event of a Grade 4-5 unexpected event based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-related AEs will be categorized overlapping systems and severities. Three categories of systems are cardiovascular, respiratory, or infectious. Two categories of severity will be serious adverse (SAE) and major adverse cardiac events (MACE). Binomial confidence Intervals at the 95% confidence level and p-values for these 3 groups will be calculated. Since previous trials have not reported AEs with cBMA treatment, confidence intervals will be generated by the method of the Wilson Score Interval.
| Arm | Type | Description |
|---|---|---|
| Day 7 | EXPERIMENTAL | BKA performed at 7 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Day 14 | EXPERIMENTAL | BKA performed at 14 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Day 21 | EXPERIMENTAL | BKA performed at 21 days post autologous cBMA injection. Injection of cBMA aspirate into the index leg |
| Name | Type | Description |
|---|---|---|
| Injection of cBMA aspirate into the index leg | BIOLOGICAL | Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery |
Inclusion Criteria: 1. Be ≥ 40 and ≤90 years of age. 2. Patients requiring below knee amputation, as determined by an independent vascular specialist. 3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM for 4 injections 4 cm. apart) 4. BKA can safely be p...
Of cBMA aspirate into the index leg is an investigational therapy being studied for use in Peripheral Artery Disease, specifically to prevent wound complications in below knee amputation. It is a concentrated bone marrow aspirate product developed by Zimmer Biomet Holdings, Inc. (ZBH). The therapy is currently in Phase 1 clinical development.
Of cBMA aspirate into the index leg is developed by Zimmer Biomet Holdings, Inc., which trades under the ticker ZBH. The company is conducting clinical research on this autologous concentrated bone marrow aspirate for Peripheral Artery Disease. It is an investigational product in Phase 1 development.
Of cBMA aspirate into the index leg is in Phase 1 clinical development. It is an investigational therapy for Peripheral Artery Disease and has not been approved by the FDA. The product is being studied to prevent wound complications in below knee amputation patients.
Of cBMA aspirate into the index leg has one completed clinical trial, NCT02863926, titled 'Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)'. This Phase 1 study enrolled 6 participants with Peripheral Artery Disease, Vascular Disease, and Critical Limb Ischemia in the United States.
Of cBMA aspirate into the index leg refers to the administration of autologous concentrated bone marrow aspirate (cBMA) into the index leg. The clinical trial NCT02863926 studies the use of autologous concentrated bone marrow aspirate in preventing wound complications in below knee amputation. It is an investigational product for Peripheral Artery Disease.