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Osteogenic Graft

Autologous Osteogenic Graft for Nonunion Fracture

Phase 1

Waitlist Available

Led By Pierre-Louis Docquier

Research Sponsored by Novadip Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-, 6-, 12- and 24-months post-gs

Awards & highlights

Study Summary

This trial studied the use of an autologous 3D graft to treat children with congenital pseudarthrosis of the tibia, a bone disorder.

Who is the study for?

This trial is for children with a rare bone condition called congenital pseudarthrosis of the tibia, who have had no more than two unsuccessful surgeries to fix it. They must be in good health overall, weigh at least 11 pounds, and not have certain other medical conditions or infections that could affect bone healing.Check my eligibility

What is being tested?

The study is testing NVD-003, an innovative graft made from the patient's own cells designed to heal bones without needing a scaffold. It's given during surgery as part of this single-group study involving multiple countries and centers.See study design

What are the potential side effects?

Since NVD-003 uses the patient’s own cells and is used surgically, typical side effects might include those associated with surgical procedures such as pain at the site, infection risk, swelling, or problems with anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-, 6-, 12- and 24-months post-gs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-, 6-, 12- and 24-months post-gs

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-, 6-, 12- and 24-months post-gs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary objective: safety short (≤3 months) and mid long-term (>3-12 months): : Descriptive analysis

Secondary outcome measures

Bone formation

Bone remodeling

Bone union

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: NVD-003 bone graft implantExperimental Treatment1 Intervention

The study includes 2 important surgical procedures, the Adipose Tissue Collection (ATC) and the Grafting Surgery (GS) and 3 stages Stage 1: A screening, adipose tissue collection & NVD 003 manufacturing period. Stage 2: Grafting surgery and 12-month post-GS follow-up period. Stage 3: long-term safety follow-up period (from post-month 12 to month 24).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novadip BiosciencesLead Sponsor

4 Previous Clinical Trials

79 Total Patients Enrolled

Pierre-Louis DocquierPrincipal InvestigatorUCL St.Luc Brussels

Philip McClure, MDPrincipal InvestigatorInternational Center for Limb Lengthening Baltimore

Media Library

NVD-003 (Osteogenic Graft) Clinical Trial Eligibility Overview. Trial Name: NCT05693558 — Phase 1

Congenital Pseudarthrosis of the Tibia Research Study Groups: NVD-003 bone graft implant

Congenital Pseudarthrosis of the Tibia Clinical Trial 2023: NVD-003 Highlights & Side Effects. Trial Name: NCT05693558 — Phase 1

NVD-003 (Osteogenic Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693558 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do octogenarians qualify for this investigation?

"This clinical study is seeking participants between the ages of 2 and 8 years old."

Answered by AI

Has the NVD-003 bone graft implant gained regulatory approval from the FDA?

"Because the safety and efficacy of NVD-003 bone graft implant is still relatively unstudied, it was given a score 1 on our risk scale."

Answered by AI

Is this medical experiment actively seeking participants?

"Affirmative. Based on the information published on clinicaltrials.gov, this medical trial is accepting new patients; it was established Nov 24th 2022 and revised Jan 11th 2023. The team hopes to recruit 4 individuals from 1 site."

Answered by AI

To what extent is the population participating in this research project growing?

"Affirmative. Data on clinicaltrials.gov suggests that this investigation, which was originally advertised on November 24th 2022, is actively seeking participants. The research team needs to recruit 4 patients from a single location."

Answered by AI

To whom is participation in this experiment available?

"This trial is accepting four subjects between the ages of two and eight with congenital pseudarthrosis of their tibias. The following criteria must be fulfilled for consideration: Diagnosis of CPT accompanied by NF1 or not, minimum weight 11lbs/5kgs, a maximum of 2 orthopaedic surgeries attempted to remedy primary fracture, serology free from viruses, general health suitable for anaesthesia-instructed procedures as per local regulations; patient's parent(s) or legal guardian(s) giving written consent and confirming participation in study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia

2022. "NVD-003 in the Treatment of Congenital Pseudarthrosis of the Tibia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693558.