NCT02742857

Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

Completed Phase 1 Last updated 30 September 2020

What this trial tests

Phase 1 trial testing BQ-A Peptide Extract in Brain Death in 20 participants. Completed in 1 August 2020.

Timeline

1 July 2016

Primary endpoint
1 August 2020

1 August 2020

Quick facts

Lead sponsor	Bioquark Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	1 July 2016
Primary completion	1 August 2020
Estimated completion	1 August 2020
Sites	1 location across India

Drugs / interventions tested

• BQ-A Peptide Extract — full drug profile →
• Mesenchymal Stem Cells — full drug profile →
• Transcranial Laser Therapy
• Median Nerve Stimulator

Conditions studied

• Brain Death — all drugs for Brain Death →

Sponsor

Bioquark Inc. — full company profile →

Who can join

Adults 15 to 65, any sex, with Brain Death. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reversal of brain death as noted in clinical examination or EEG
  Time frame: 15 days

Sponsor's own description

This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trials Based on Mesenchymal Stromal Cells are Exponentially Increasing: Where are We in Recent Years?
   Galderisi U, Peluso G, Di Bernardo G. · · 2022 · cited 175× · PMID 34398443 · DOI 10.1007/s12015-021-10231-w
2. Differentiation of Human Mesenchymal Stem Cells towards Neuronal Lineage: Clinical Trials in Nervous System Disorders.
   Hernández R, Jiménez-Luna C, Perales-Adán J, Perazzoli G, et al · · 2020 · cited 95× · PMID 31649208 · DOI 10.4062/biomolther.2019.065
3. Traumatic Brain Injury and Stem Cells: An Overview of Clinical Trials, the Current Treatments and Future Therapeutic Approaches.
   Schepici G, Silvestro S, Bramanti P, Mazzon E. · · 2020 · cited 40× · PMID 32204311 · DOI 10.3390/medicina56030137
4. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
5. Cell-Based Therapies for Traumatic Brain Injury: Therapeutic Treatments and Clinical Trials.
   Bonilla C, Zurita M. · · 2021 · cited 30× · PMID 34200905 · DOI 10.3390/biomedicines9060669
6. Stem Cells in Clinical Trials on Neurological Disorders: Trends in Stem Cells Origins, Indications, and Status of the Clinical Trials.
   Namiot ED, Niemi JVL, Chubarev VN, Tarasov VV, et al · · 2022 · cited 18× · PMID 36232760 · DOI 10.3390/ijms231911453
7. Enduring Neuroprotective Effect of Subacute Neural Stem Cell Transplantation After Penetrating TBI.
   Kassi AAY, Mahavadi AK, Clavijo A, Caliz D, et al · · 2018 · cited 10× · PMID 30719019 · DOI 10.3389/fneur.2018.01097
8. Mesenchymal stromal cell therapies for traumatic neurological injuries.
   Wang X, Wang Q, Xia Z, Yang Y, et al · · 2024 · cited 5× · PMID 39578845 · DOI 10.1186/s12967-024-05725-3