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Can bone marrow cells supercharge cleft bone grafts?

NCT ID NCT07786259

Disease control Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests whether adding a patient's own bone marrow concentrate to a bovine bone graft improves healing and bone regrowth in people born with a unilateral alveolar cleft. Half of the 16 participants receive the enriched graft, while the other half gets the standard bovine graft alone. Over six months, the study measures bone integration, resorption, and defect fill using CT scans, along with pain, soft-tissue healing, and tooth eruption. The goal is to see if the bone marrow boost leads to better, more durable bone repair.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous bone marrow aspirate concentrate (BMAC) combined with bovine-derived bone graft
What this could lead to
If adding BMAC improves bone regeneration, it could lead to a more effective and reliable surgical approach for repairing alveolar clefts, potentially reducing the need for additional surgeries.
What could go wrong
This is a small, early-stage trial with only 16 participants, so results may not apply broadly. The procedure involves bone marrow aspiration, which carries risks like pain, bleeding, or infection, and the added benefit of BMAC is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Started

Mar 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients with unilateral alveolar clefts requiring repair. Patients with good oral hygiene and good general health. Patients free from any systemic disease that may affect normal bone healing. Patients aged 7 to 25 years. Absence of blood disorders that might cause complications following bone marrow aspiration. Exclusion Criteria: Patients with bilateral alveolar clefts. Patients with local maxillary pathosis that may interfere with surgery. Immunocompromised patients. Patients with syndromes associated with alveolar cleft.

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Conditions

The condition(s) this trial relates to.

cleft lip and alveolus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unilateral alveolar cleft of maxilla

Contacts and locations

Locations

  • Faculty of Dentistry, Tanta University

    Tanta, Gharbia Governorate, 31527, Egypt

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