BioMatrix is currently engaged in clinical trials addressing critical challenges in the field of solid organ transplant.

Our services are helping advance research enhancing the safety and quality of therapies, improving patient outcomes, and reducing overall healthcare expenditures.

We accomplish this by aiding targeted research with a direct impact in living and deceased donor desensitization, preemptive DSA, and acute/chronic biologic therapeutic interventions for post-transplant complications.

We provide the following clinical trial services:

  • Trial drug dispensation and administration

  • Data collection and pharmacovigilance

  • Trial design consultation

  • Research coordination

  • Publication strategy and assistance

  • Financial sponsorship and support

Below represents BioMatrix’s involvement in ongoing and completed clinical trials:

2015: BMS/Bela Home Infusion Safety Study

  • Home infusion visits were obtained from a BioMatrix service provider (BiologicTx). All patients who received Belatacept at home, from June 2011 to September 2014.

  • 45 Patients receiving Belatacept through the BioMatrix home infusion service during the study period

  • Out of 382 home infusion visits, there was no report of adverse and serious adverse event within 24 hours after a visit

  • Published and presented ATC 2015

  • [View on ClinicalTrials.gov]

2019: USC/BioMatrix Lung Desensitization Study

  • 36 Lung transplant patients who received desensitization, 17 were transplanted achieving an effective transplant rate of 47% to date

  • IG 2gm/kg for all patients, some also add Rituxan q6mo

  • The actuarial survival at 1-, 3- and 5-years was 92%, 69%, and 52%, respectively. Compared to the non-desensitized lung transplant patients that were transplanted at USC between 2013 and 2017, graft survival rates were similar.

  • Whitepaper published with highlights 2019, presented at ATC 2019

  • Study is continuous, active today

2018–Current: VCU–Multicenter Desensitization Protocol / Retrospective Trial / BioMatrix Exclusive

  • Virginia Common Wealth University- Gupta- PI, Rhode Island -Gohh, Baylor TX- Yango, University Texas Med Branch-Mujtaba, Indiana University- Sharfuddin, Loma Linda CA-Villicana, UPMC- Singh

  • Medications: IG (high dose) & Actemra

  • Pre-Living and deceased donor listed kidney transplant patients with cPRA >80%, majority are >99%cPRA

  • 57 Referrals for the protocol/32 currently enrolled(active)/11 completed protocol/13 transplanted (during or after protocol)

  • Current data supports 50% or more decrease in overall antibody MFI for all patients in participation

  • Not published yet–still active trial

2019–Current: BK Viremia Post Kidney Trial

  • Massachusetts General Hospital, Weill-Cornell Medical Center, Beth Israel Deaconess Medical Center

  • Double-Blind study–IG 1gm/kg or placebo

  • Verifying participant / enrollment

  • Not published yet–still active trial

2013–2018: Regional Kidney Paired Donor Exchange in Sensitized Patients

  • Prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients

  • Measures the rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program