# Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)

> **NCT01049919** · NA · TERMINATED · sponsor: **Zimmer Biomet** · enrollment: 153 (actual)

## Conditions studied

- Critical Limb Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Disease

## Interventions

- **DEVICE:** Bone marrow concentration device
- **PROCEDURE:** Placebo procedure (sham)

## Key facts

- **NCT ID:** NCT01049919
- **Lead sponsor:** Zimmer Biomet
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2010-06
- **Primary completion:** 2016-06
- **Final completion:** 2020-02
- **Target enrollment:** 153 (ACTUAL)
- **Why stopped:** Primary endpoint not met, remaining long-term follow-up not needed.
- **Last updated:** 2021-05-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01049919

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01049919, "Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01049919. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*