Pilot Study in South Africa
Overview
BHA has been tested in humans in a double arm phase II Multi-center Randomized Clinical Trial (“RCT”), HEAL I (Healing Enhanced & Accelerated in Long bone fracture) and demonstrated promising results regarding the therapeutic potential of BHA. The primary objective was to evaluate the safety and performance of the Bone Healing Accelerant as an adjunct in the treatment of open tibia fractures. (This first-in-human trial was not powered). Observations suggested that BHA use was associated with accelerated fracture and soft tissue healing and a lower incidence of infection (through 1 year). Overall, there were fewer adverse events reported in the BHA treated group relative to controls.
A total of 20 treatment patients and 10 controls were enrolled at two hospitals in Cape Town, South Africa. Follow-up examinations, including X-ray and clinical assessments, occurred at 14, 30, 60, 90, 180, and 365 days. The primary endpoints of the study were safety and radiographic evidence of fracture healing; secondary endpoints included infections, wound closure, adverse events, pain, swelling and tenderness.
Safety
Adverse Events:
There were no adverse events reported related to the use of the BHA throughout the year-long study.
Secondary Endpoints
Infection
There were no adverse events reported related to the use of the BHA throughout the year-long study.
% Patients w 1+ Infections through 1 year
| Type of Injuries | Bone Healing Accelerant | Control | P‑Value |
|---|---|---|---|
| All Injuries | 22.2% | 80.0% | 0.0048 |
| IIIA and IIIB injuries | 25.0% | 100.0% | 0.00024 |
Soft Tissue Wound Healing at 30 Days
More BHA treated subjects were observed to have had their soft tissue wounds healed at 30 days than in the control group.
% Wounds Healed, 30 days
| Type of Injuries | Bone Healing Accelerant | Control | P‑Value |
|---|---|---|---|
| All Injuries | 41.2% | 11.1% | 0.1276 |
| IIIA and IIIB injuries | 36.4% | 0.0% | 0.1078 |
Efficacy- Tibia Fracture Healing
Subjects treated with BHA were observed to have numerically more fracture cortices bridged by bone relative to control subjects. This finding was most pronounced in subjects with Grade IIIA and IIIB injuries.
Bone Healing - Mean Cortices Bridged, 180 days
| Type of Injuries | Bone Healing Accelerant | Control | P‑Value |
|---|---|---|---|
| All Injuries | 2.35 | 1.89 | 0.1769 |
| IIIA and IIIB injuries | 2.64 | 1.33 | 0.0445 |